Metastatic NeoplasmPhase 1/2NCT04418661
Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies
A Phase 1/2 study testing Vociprotafib, Pembrolizumab and Adagrasib in people with Metastatic Neoplasm, run by Sanofi at 20 sites in 7 countries.
Trial summary
Primary Objectives: Part 1 To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors. To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in participants with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Neoplasm
- What is being tested?
- Vociprotafib, Pembrolizumab and Adagrasib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 9 Jun 2020to 4 Apr 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be ≥ 18 years of age.
- Histologically proven diagnosis of advanced solid tumors.
- Participants must have one or more of the following molecular aberrations (Part 1): KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations.
- Participants must have following molecular aberration (Part 3A and 3B): - KRAS G12C mutation.
- At least 1 measurable disease per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Woman of childbearing potential must agree to follow contraceptive guidance.
- Capable of giving signed informed consent.
Who cannot join
- Predicted life expectancy <3 months.
- Primary central nervous system (CNS) tumors.
- Symptomatic or impending cord compression. Stable CNS disease was allowed.
- History of cerebrovascular stroke or transient ischemic attack within previous 6 months.
- Prior solid organ or hematologic transplant.
- History or current retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vascular occlusion (RVO), neovascular macular degeneration.
Show all 17Show fewer
- Any clinically significant cardiac disease.
- Active, known or suspected autoimmune disease.
- History of or current interstitial lung disease or pneumonitis.
- Receipt of a live-virus vaccination within 28 days, viral vaccine that do not contain live virus within 7 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- Known infection with human immunodeficiency virus (HIV), known uncontrolled hepatitis B infection, active tuberculosis, or severe infection requiring parenteral antibiotic treatment.
- Inadequate hematologic, hepatic and renal function.
- Known second malignancy.
- Impairment of gastrointestinal function.
- Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol.
- History of severe allergic reaction to any of the study intervention components.
- The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
Argentina4 sites
Investigational Site Number : 0320001
Buenos Aires, 1019
Investigational Site Number : 0320004
Buenos Aires, 1093
Investigational Site Number : 0320002
Buenos Aires, 1125
Investigational Site Number : 0320003
Rosario, Santa Fe Province, 2000
Australia3 sites
Investigational Site Number : 0360003
Melbourne, Victoria, 3084
Investigational Site Number : 0360002
Sydney, New South Wales, 2031
Investigational Site Number : 0360001
Woolloongabba, Queensland, 4102
Chile3 sites
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 8420383
Investigational Site Number : 1520002
Temuco, La Araucanía, 4780000
Investigational Site Number : 1520003
Viña del Mar, Valparaiso, 2520598
South Korea3 sites
Investigational Site Number : 4100003
Cheongju-si, North Chungcheong, 28644
Investigational Site Number : 4100002
Seongnam-si, Gyeonggi-do, 13496
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, 03722
Spain3 sites
Investigational Site Number : 7240001
Madrid, 28040
Investigational Site Number : 7240002
Madrid, 28050
Investigational Site Number : 7240003
Valencia, 46010
United States2 sites
The University of Texas MD Anderson Cancer Center- Site Number : 8400001
Houston, Texas, 77030
University of California Irvine Medical Center- Site Number : 8400002
Orange, California, 92868
Taiwan2 sites
Investigational Site Number : 1580002
Tainan, 704
Investigational Site Number : 1580001
Taipei, 100
About this study
Official title: A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of SAR442720 in Combination With Other Agents in Participants With Advanced Malignancies
Primary Objectives:
- Part 1
- To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors.
- To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in participants with solid tumors.
- Part 2
- To determine the anti-tumor activity of SAR442720 in combination with pembrolizumab.
- Part 3A
- To define the MTD and RP2D for the combination of SAR442720 and adagrasib in participants with KRAS G12C NSCLC
- To characterize the safety and tolerability of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC
- Part 3B
- To determine the anti-tumor activity of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC
- Part 4
- To evaluate the impact of food on the PK of SAR442720 when dosed with pembrolizumab.
- To evaluate the impact of the formulations (formulation 1 and formulation 2) on the PK of SAR442720 when dosed with pembrolizumab.
Read more
Secondary Objectives:
- Part 1
- To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720.
- To estimate the anti-tumor effects of SAR442720 with pembrolizumab.
- Part 2
- To assess the safety profile of SAR442720 combined with pembrolizumab.
- To assess other indicators of anti-tumor activity.
- To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720.
- Part 3A
- To characterize the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720.
- To estimate the anti-tumor effects of SAR442720 with adagrasib
- Part 3B
- To assess the safety profile of SAR442720 with adagrasib in participants with KRAS G12C NSCLC.
- To assess other indicators of anti-tumor activity.
- To assess the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720.
- Part 4
- To assess the safety and tolerability of SAR442720 formulations with pembrolizumab
- To estimate the anti-tumor effects of SAR442720 with pembrolizumab.
Read the detailed description
This open label Phase 1 multicenter study was designed to evaluate the safety and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SAR442720 in combination with pembrolizumab in participants with solid tumors in Part 1.
In Part 2, in the expansion cohort (Cohort A) we assessed the antitumor activity and safety of SAR442720 combined with pembrolizumab in participants with metastatic 1L lung cancer.
In Part 3, we evaluated the safety, MTD, RP2D and antitumor activity of SAR442720 in combination with adagrasib in participants with lung cancer and KRAS G12C mutation.
In Part 4, we evaluated the impact of the formulations (formulation 1 and formulation 2) and of the food on the PK of SAR442720 when dosed in combination with pembrolizumab. The expected duration of study intervention for participants may vary, based on progression date; median expected duration of study per participant was estimated to be about 10 months in Part 1, Part 3 and Part 4 (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up) and in Part 2 16 months (up to 1 month for screening, a median of 12 months for treatment and a median of 3 months for long term follow up.)
- Conditions
- Metastatic Neoplasm
- Being tested
- Vociprotafib, Pembrolizumab, Adagrasib
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VociprotafibDrug
Also called SAR442720, RMC-4630
Pharmaceutical form: Varies Route of administration: Varies
PembrolizumabDrug
Pharmaceutical form:Sterile Lyophilized powder for reconstitution Route of administration: Infusion
AdagrasibDrug
Pharmaceutical form:Sterile Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Part 1- SAR442720 140 mg BIW + Pembrolizumab | Experimental | Participants were administered SAR442720 140 milligram (mg) orally twice a week (BIW) on Days 1 and 4 along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day cycles until disease progression, unacceptable adverse events (AEs), or the participant's or investigator's decision to stop the treatment. Receives: Drug: Vociprotafib; Drug: Pembrolizumab |
| Part 1- SAR442720 200mg BIW + Pembrolizumab | Experimental | Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment. Receives: Drug: Vociprotafib; Drug: Pembrolizumab |
| Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%) | Experimental | Participants with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS)>=50% non-small cell lung cancer (NSCLC) were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg once in every 6 weeks (Q6W) (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment. Receives: Drug: Vociprotafib; Drug: Pembrolizumab |
| Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%) | Experimental | Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment. Receives: Drug: Vociprotafib; Drug: Pembrolizumab |
| Part 3A- SAR442720 100mg BIW + Adagrasib | Experimental | Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg orally twice daily (BID) in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment. Receives: Drug: Vociprotafib; Drug: Adagrasib |
| Part 4- SAR442720 200mg + Pembrolizumab | Experimental | Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment. Receives: Drug: Vociprotafib; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
Measured: From first dose of IMP up to 30 days after the last dose; approximately 27 weeks
Parts 1 and 3A: Number of Participants With Treatment Related Dose Limiting Toxicities (DLTs)
Potential DLTs were defined as the AEs that occurred during the first cycle (C) of treatment, considered by the investigator to be related to IMP, unless due to disease progression or to a cause obviously unrelated to IMP: Grade(G)>= 4 AEs, G3 neutropenia lasting >7 days or febrile neutropenia; G3 thrombocytopenia with clinically significant bleeding; any G>=3 immune-related AEs; G3 nonhematologic AEs; G3 aspartate transaminase, alanine transaminase, and/or total bilirubin elevations that persist >5 days; possible Hy's law case; G3 QT interval corrected using Fridericia's formula prolongation; retinal vein occlusion any grade; toxicity related to IMP leading to 50% or less dose intensity of SAR442720 and/or delay in initiation of C2 dosing of pembrolizumab by >15 days, in the absence of recovery to baseline or G <=1 AE. Potential DLT were reviewed by Sponsor and investigators to confirm them as DLTs.
Measured: Cycle 1 (21 days)
Part 2: Percentage of Participants With Objective Response Rate (ORR)
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) determined by investigator per response evaluation criteria in solid tumors (RECIST) version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 millimeter (mm) OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The confidence interval (CI) was estimated using Clopper-Pearson method.
Measured: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 3A: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
Measured: From first dose of IMP up to 30 days after the last dose; approximately 7 weeks
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
Plasma samples were collected at specified timepoints for pharmacokinetic (PK) analysis.
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on C1 D1, C1 D15, C2 D1; Pre-dose on C1 D8 and C6 D1; end of treatment (Week 45)
Part 4: Area Under Curve From Zero to Last Concentration Timepoint (AUClast) for SAR442720 Tablets and Capsules
Plasma samples were collected at specified timepoints to determine AUClast for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using non-compartmental analysis (NCA) method.
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2D1
Part 4: Maximum Observed Plasma Concentration (Cmax) for SAR442720 Tablets and Capsules
Plasma samples were collected at specified timepoints to determine Cmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1
Part 4: Time to Reach Maximum Plasma Concentration (Tmax) for SAR442720 Tablets and Capsules
Plasma samples were collected at specified timepoints to determine tmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.
Measured: Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1
Secondary outcomes (16)
Part 1: Plasma Concentration of SAR442720
Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.
Measured: Pre-dose, 2, 8, hours post-dose on C1 D1 and C2D1; pre-dose C1D8, C1D15, and C6D1; 2 hours C2D2; and end of treatment (Week 22)
Part 2: Plasma Concentration of SAR442720
Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.
Measured: Pre-dose and 2 hours post-dose C1D1 and C2D1; pre-dose on C1D8, C1D15, C6D1; and end of treatment (Week 104)
Parts 1 and 2: Serum Concentration of Pembrolizumab
Serum samples were collected at specified timepoints for evaluation of pembrolizumab PK concentrations.
Measured: Pre-dose and post-dose C1D1; pre-dose on C2D1 and C6D1
Parts 1 and 4: Percentage of Participants With Objective Response Rate
ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.
Measured: Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks (Part 1), 46 weeks (Part 4)
Part 1: Duration of Response (DoR)
DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive disease progression(PD) or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.
Measured: Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks
Part 2: Duration of Response
DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5mm. DoR was estimated using Kaplan-Meier method.
Measured: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 2: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
Measured: From first dose of IMP up to 30 days after the last dose; approximately 111 weeks
Part 4: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
Measured: From first dose of IMP up to 30 days after the last dose; approximately 50 weeks
Part 2: Time to Response (TTR)
TTR was defined as the time interval from the administration of first IMP dose to the first documented evidence of PR or CR determined by the Investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. TTR was estimated using Kaplan-Meier method.
Measured: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 2: Percentage of Participants With Clinical Benefit Rate
Clinical benefit rate was defined as the percentage of participants with confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. The CI was estimated using Clopper-Pearson method.
Measured: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 2: Percentage of Participants With Disease Control Rate
Disease control rate was defined percentage of participants with confirmed CR or PR or SD as determined by the investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. The CI was estimated using Clopper-Pearson method.
Measured: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 2: Progression Free Survival (PFS)
PFS was defined as the time from the date of first IMP administration to the date of the first documented PD determined by the investigator per RECIST version 1.1 or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. PFS was estimated using Kaplan-Meier method.
Measured: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 3A: Plasma Concentration of SAR442720
Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations. It was calculated using NCA method.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post-dose C1D1; pre-dose C1D8; pre-dose, 0.5, 1, 2, 4, 6 post-dose C1D15, and end of treatment (Week 3)
Part 3A: Plasma Concentration of Adagrasib
Plasma samples were collected at specified timepoints for evaluation of adagrasib PK concentrations. It was calculated using NCA method.
Measured: Pre-dose, 1, 2, 4, 6, 8 post-dose C1D1 and C1D15; pre-dose C1D8
Part 3A: Percentage of Participants With Objective Response Rate
ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.
Measured: Tumor assessments performed till end of treatment, approximately 3 weeks
Part 3A: Duration of Response
DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.
Measured: Tumor assessments performed till end of treatment, approximately 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start9 Jun 2020
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Why it stopped: Sponsor's decision not related to any safety concern
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic NeoplasmStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Revolution Medicines, Inc., Mirati Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418661
- Sponsor's protocol ID
- TCD16210
- Other IDs
- U1111-1244-2555, TCD16210, 2020-000436-22
- Status last verified
- May 2025
- First submitted
- 29 May 2020
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of SAR442720 in Combination With Other Agents in Participants With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT04418661
- Acronym / sponsor ID
- TCD16210
- Conditions
- Metastatic Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision not related to any safety concern
- Enrolment
- 65 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Revolution Medicines, Inc., Mirati Therapeutics Inc.
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- Part 1
- To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors.
- To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in participants with solid tumors.
- Part 2
- To determine the anti-tumor activity of SAR442720 in combination with pembrolizumab.
- Part 3A
- To define the MTD and RP2D for the combination of SAR442720 and adagrasib in participants with KRAS G12C NSCLC
- To characterize the safety and tolerability of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC
- Part 3B
- To determine the anti-tumor activity of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC
- Part 4
- To evaluate the impact of food on the PK of SAR442720 when dosed with pembrolizumab.
- To evaluate the impact of the formulations (formulation 1 and formulation 2) on the PK of SAR442720 when dosed with pembrolizumab.
Secondary Objectives:
- Part 1
- To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720.
- To estimate the anti-tumor effects of SAR442720 with pembrolizumab.
- Part 2
- To assess the safety profile of SAR442720 combined with pembrolizumab.
- To assess other indicators of anti-tumor activity.
- To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720.
- Part 3A
- To characterize the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720.
- To estimate the anti-tumor effects of SAR442720 with adagrasib
- Part 3B
- To assess the safety profile of SAR442720 with adagrasib in participants with KRAS G12C NSCLC.
- To assess other indicators of anti-tumor activity.
- To assess the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720.
- Part 4
- To assess the safety and tolerability of SAR442720 formulations with pembrolizumab
- To estimate the anti-tumor effects of SAR442720 with pembrolizumab.
Detailed description
This open label Phase 1 multicenter study was designed to evaluate the safety and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SAR442720 in combination with pembrolizumab in participants with solid tumors in Part 1.
In Part 2, in the expansion cohort (Cohort A) we assessed the antitumor activity and safety of SAR442720 combined with pembrolizumab in participants with metastatic 1L lung cancer.
In Part 3, we evaluated the safety, MTD, RP2D and antitumor activity of SAR442720 in combination with adagrasib in participants with lung cancer and KRAS G12C mutation.
In Part 4, we evaluated the impact of the formulations (formulation 1 and formulation 2) and of the food on the PK of SAR442720 when dosed in combination with pembrolizumab. The expected duration of study intervention for participants may vary, based on progression date; median expected duration of study per participant was estimated to be about 10 months in Part 1, Part 3 and Part 4 (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up) and in Part 2 16 months (up to 1 month for screening, a median of 12 months for treatment and a median of 3 months for long term follow up.)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1- SAR442720 140 mg BIW + Pembrolizumab | Experimental | Drug: Vociprotafib, Drug: PembrolizumabParticipants were administered SAR442720 140 milligram (mg) orally twice a week (BIW) on Days 1 and 4 along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day cycles until disease progression, unacceptable adverse events (AEs), or the participant's or investigator's decision to stop the treatment. |
| Part 1- SAR442720 200mg BIW + Pembrolizumab | Experimental | Drug: Vociprotafib, Drug: PembrolizumabParticipants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment. |
| Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%) | Experimental | Drug: Vociprotafib, Drug: PembrolizumabParticipants with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS)>=50% non-small cell lung cancer (NSCLC) were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg once in every 6 weeks (Q6W) (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment. |
| Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%) | Experimental | Drug: Vociprotafib, Drug: PembrolizumabParticipants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment. |
| Part 3A- SAR442720 100mg BIW + Adagrasib | Experimental | Drug: Vociprotafib, Drug: AdagrasibParticipants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg orally twice daily (BID) in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment. |
| Part 4- SAR442720 200mg + Pembrolizumab | Experimental | Drug: Vociprotafib, Drug: PembrolizumabParticipants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must be ≥ 18 years of age.
- Histologically proven diagnosis of advanced solid tumors.
- Participants must have one or more of the following molecular aberrations (Part 1): KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations.
- Participants must have following molecular aberration (Part 3A and 3B): - KRAS G12C mutation.
- At least 1 measurable disease per RECIST 1.1 criteria.
Key exclusion criteria (17 listed)
- Predicted life expectancy <3 months.
- Primary central nervous system (CNS) tumors.
- Symptomatic or impending cord compression. Stable CNS disease was allowed.
- History of cerebrovascular stroke or transient ischemic attack within previous 6 months.
- Prior solid organ or hematologic transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VociprotafibAlso: SAR442720, RMC-4630Pharmaceutical form: Varies Route of administration: Varies | Drug | Part 1- SAR442720 140 mg BIW + Pembrolizumab, Part 1- SAR442720 200mg BIW + Pembrolizumab, Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%), Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%), Part 3A- SAR442720 100mg BIW + Adagrasib, Part 4- SAR442720 200mg + Pembrolizumab |
| PembrolizumabPharmaceutical form:Sterile Lyophilized powder for reconstitution Route of administration: Infusion | Drug | Part 1- SAR442720 140 mg BIW + Pembrolizumab, Part 1- SAR442720 200mg BIW + Pembrolizumab, Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%), Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%), Part 4- SAR442720 200mg + Pembrolizumab |
| AdagrasibPharmaceutical form:Sterile Tablet Route of administration: Oral | Drug | Part 3A- SAR442720 100mg BIW + Adagrasib |
Primary outcome
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From first dose of IMP up to 30 days after the last dose; approximately 27 weeks
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
Parts 1 and 3A: Number of Participants With Treatment Related Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (21 days)
Potential DLTs were defined as the AEs that occurred during the first cycle (C) of treatment, considered by the investigator to be related to IMP, unless due to disease progression or to a cause obviously unrelated to IMP: Grade(G)>= 4 AEs, G3 neutropenia lasting >7 days or febrile neutropenia; G3 thrombocytopenia with clinically significant bleeding; any G>=3 immune-related AEs; G3 nonhematologic AEs; G3 aspartate transaminase, alanine transaminase, and/or total bilirubin elevations that persist >5 days; possible Hy's law case; G3 QT interval corrected using Fridericia's formula prolongation; retinal vein occlusion any grade; toxicity related to IMP leading to 50% or less dose intensity of SAR442720 and/or delay in initiation of C2 dosing of pembrolizumab by >15 days, in the absence of recovery to baseline or G <=1 AE. Potential DLT were reviewed by Sponsor and investigators to confirm them as DLTs.
Part 2: Percentage of Participants With Objective Response Rate (ORR)
Time frame: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) determined by investigator per response evaluation criteria in solid tumors (RECIST) version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 millimeter (mm) OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The confidence interval (CI) was estimated using Clopper-Pearson method.
Part 3A: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Time frame: From first dose of IMP up to 30 days after the last dose; approximately 7 weeks
AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on C1 D1, C1 D15, C2 D1; Pre-dose on C1 D8 and C6 D1; end of treatment (Week 45)
Plasma samples were collected at specified timepoints for pharmacokinetic (PK) analysis.
Part 4: Area Under Curve From Zero to Last Concentration Timepoint (AUClast) for SAR442720 Tablets and Capsules
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2D1
Plasma samples were collected at specified timepoints to determine AUClast for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using non-compartmental analysis (NCA) method.
Part 4: Maximum Observed Plasma Concentration (Cmax) for SAR442720 Tablets and Capsules
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1
Plasma samples were collected at specified timepoints to determine Cmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.
Part 4: Time to Reach Maximum Plasma Concentration (Tmax) for SAR442720 Tablets and Capsules
Time frame: Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1
Plasma samples were collected at specified timepoints to determine tmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.
16 secondary outcomes
Part 1: Plasma Concentration of SAR442720
Time frame: Pre-dose, 2, 8, hours post-dose on C1 D1 and C2D1; pre-dose C1D8, C1D15, and C6D1; 2 hours C2D2; and end of treatment (Week 22)
Part 2: Plasma Concentration of SAR442720
Time frame: Pre-dose and 2 hours post-dose C1D1 and C2D1; pre-dose on C1D8, C1D15, C6D1; and end of treatment (Week 104)
Parts 1 and 2: Serum Concentration of Pembrolizumab
Time frame: Pre-dose and post-dose C1D1; pre-dose on C2D1 and C6D1
Parts 1 and 4: Percentage of Participants With Objective Response Rate
Time frame: Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks (Part 1), 46 weeks (Part 4)
Part 1: Duration of Response (DoR)
Time frame: Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks
Part 2: Duration of Response
Time frame: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 2: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Time frame: From first dose of IMP up to 30 days after the last dose; approximately 111 weeks
Part 4: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Time frame: From first dose of IMP up to 30 days after the last dose; approximately 50 weeks
Part 2: Time to Response (TTR)
Time frame: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 2: Percentage of Participants With Clinical Benefit Rate
Time frame: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 2: Percentage of Participants With Disease Control Rate
Time frame: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 2: Progression Free Survival (PFS)
Time frame: Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
Part 3A: Plasma Concentration of SAR442720
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post-dose C1D1; pre-dose C1D8; pre-dose, 0.5, 1, 2, 4, 6 post-dose C1D15, and end of treatment (Week 3)
Part 3A: Plasma Concentration of Adagrasib
Time frame: Pre-dose, 1, 2, 4, 6, 8 post-dose C1D1 and C1D15; pre-dose C1D8
Part 3A: Percentage of Participants With Objective Response Rate
Time frame: Tumor assessments performed till end of treatment, approximately 3 weeks
Part 3A: Duration of Response
Time frame: Tumor assessments performed till end of treatment, approximately 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- TCD16210 Plain language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Related trials for Metastatic Neoplasm
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vociprotafib, Pembrolizumab and Adagrasib in people with Metastatic Neoplasm, run by Sanofi at 20 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Argentina, Australia, Chile, South Korea, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: From first dose of IMP up to 30 days after the last dose; approximately 27 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.