Solid TumorPhase 1/2NCT05584670
A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
A Phase 1/2 study testing SAR445877, Cetuximab and ADG126 in people with Solid Tumor, run by Sanofi at 22 sites in 6 countries.
Trial summary
This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with other anticancer therapies for participants aged at least 18 years with advanced unresectable or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- SAR445877, Cetuximab and ADG126
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 29 Nov 2022to 28 Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Dose escalation Part 1A and Japan Cohort F
- Participants with advanced unresectable or metastatic solid tumors for which, in the judgement of the investigator, no standard alternative therapy is available or is not in the best interest of the participant
- Dose escalation Part 1B
- Participants with advanced unresectable or metastatic melanoma, NSCLC; renal cell carcinoma (RCC); HCC, colorectal cancer (MSI-H/dMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC). and for who, in the judgement of the investigator, no standard alternative therapy is available or is not in the best interest of the participant.
- Dose escalation Part 1C
- Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer
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- Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.
- Dose expansion/optimization Part 2
- Cancer diagnosis:
- Participants in Cohorts A1 and A2 (Part 2A): Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
- Participants in Cohort B (part 2A): Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic hepatocellular carcinoma (HCC), or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants (participants without cirrhosis must have had histological confirmation of diagnosis)
- Participants in Cohorts C1 and C2 (part 2A):
- Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic gastric cancer (GC) or Siewert Type 2 \& 3 gastro esophageal junction (GEJ) adenocarcinoma
- Disease with any CPS scoring. No need for CPS determination at local laboratory
- Participants must have MSI (metastatic microsatellite instability) or MMR (mismatch repair) status known or determined locally and must have non-MSI-H or proficient MMR (pMMR) disease to be eligible.
- Participants with unknown HER2/neu status must have their HER2/neu status determined locally. Participants with HER2/neu negative are eligible. Participants with HER2/neu positive tumors must have documentation of disease progression on treatment containing an approved HER2 targeted therapy to be eligible.
- Participants in Part 2A Cohorts E1 and E2, Part 2B Cohort E3 and Part 2D Cohorts H1 and H2: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer.
- Participants in Part 2A Cohorts E1, and E2 and Part 2B Cohort E3 MSI status:
- Participants must have MSI status known or determined locally and must have non- MSI-H disease to be eligible.
- Participants in Part 2A Cohorts E1, E2, Part 2B Cohort E3 and Part 2D Cohorts H1 and H2: Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.
- Part 2C Cohorts G1, G2 and G3: Participants with histologically confirmed unresectable locally advanced or metastatic melanoma
- Prior anticancer therapy (For dose expansion/optimization Part 2 only)
- Participants in Cohorts A1 and A2: Participants must have received at least 1 systemic therapy for the metastatic setting and must not be amenable to the available SOC.
- Participants in Cohort B: Participants who have received at least 1 prior anticancer therapy, including an anti-PD1/PD-L1 containing regimen, and for whom have progressed after a primary or secondary resistance to an anti-PD1/PD-L1.
- Participants in Cohorts C1 and C2: Participants should have failed or relapsed after at least 1 prior line of treatment which may or may not include an anti-PD1/PD-L1-based treatment depending on local standard of care.
- Participants in Cohort D: Participants must have received at least 1 systemic therapy for their advanced/ metastatic setting and must not be amenable to the available SOC.
- Participants in Part 2A Cohorts E1 and E2 and Part 2D Cohorts H1 and H2 should have failed or relapsed on at least 2 prior regimens.
- Participants in cohort E3 should have failed or relapsed on at least 1 prior regimen. Participants who have received cetuximab or other anti-EGFR therapy as part of their prior line of treatment are eligible.
- Part 2C Cohorts G1, G2 and G3: Participants must have received at least one prior line of therapy for advanced/metastatic melanoma and/or does not have any standard of care (SoC) treatment option or decline or is intolerant to be treated with SoC treatment.
- Measurable Disease:
- At least 1 measurable lesion per RECIST 1.1 criteria
- Part 1C and Part 2D: Adequate coagulation function for all participants. For participants receiving anti-coagulant therapy (except platelet anti-aggregates) the adequate therapeutic levels of INR should be confirmed.
- Capable of giving signed informed consent.
Who cannot join
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
- Predicted life expectancy ≤3 months
- For participants with HCC- Cohort B (Part 2): Child Pugh Class B or C liver score. Participants with Child Pugh Class B-7 score are allowed for Part 1.
- Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment
- Known active brain metastases or leptomeningeal metastases
- History of treatment-related immune-mediated (or immune-related) AEs from immune-modulatory agents (including but not limited to anti-PD1/PD-L1 agents and anti-cytotoxic T lymphocyte associated protein 4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were Grade 4 in severity or have not resolved to Grade ≤1
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- Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or an anti-inflammatory equivalent) within 1 week prior to the first dose of the study medicine
- Any clinically significant cardiac (including valvular) or vascular (thromboembolic disorders) disease, within 6 months prior to the first IMP administration
- Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
- Has a known history or any evidence of interstitial lung disease or active, non-infectious pneumonitis within 3 years prior to the first dose of the study drug.
- Organ transplant requiring immunosuppressive treatment
- Uncontrolled or active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or has a diagnosis of immunodeficiency
- NOTE: Other Inclusion/Exclusion criteria may apply.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
22 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
22 sites in 6 countries
United States9 sites, 9 recruiting
- Recruiting
Karmanos Cancer Institute - Detroit- Site Number : 8400006
Detroit, Michigan, 48201
Ammar Sukari, 313-576-8751, sukaria@karmanos.org
Ammar Sukari
- Recruiting
John Theurer Cancer Center- Site Number : 8400001
Hackensack, New Jersey, 07601
Suzanne Kosky, 551-996-3986, suzanne.kosky@hmhn.org
Martin Gutierrez
- Recruiting
The University of Texas MD Anderson Cancer Center- Site Number : 8400005
Houston, Texas, 77030
Aung Naing, 713-794-5555, anaing@mdanderson.org
Aung Naing
- Recruiting
University of Iowa- Site Number : 8400014
Iowa City, Iowa, 52242
Muhammad Furquan, 319-356-1527, muhammad-furqan@uiowa.edu
Muhammad Furquan
- Recruiting
NYU Langone Medical Center- Site Number : 8400013
New York, New York, 10016
Paul Oberstein, 212-731-6120, paul.oberstein@nyulangone.org
Paul Oberstein
- Recruiting
Christiana Care Health System - Newark- Site Number : 8400011
Newark, Delaware, 19718
Jamal Misleh, 302-366-1200, Jamal.misleh@usoncology.com
Jamal Misleh
- Recruiting
Rhode Island Hospital - Providence - Eddy Street- Site Number : 8400004
Providence, Rhode Island, 02905
Kaitlyn Krar, 401-444-4818 ext. 401-444-8441, CKrar@Lifespan.org
Khaldoun Almhanna
- Recruiting
Fred Hutchinson Cancer Center- Site Number : 8400010
Seattle, Washington, 98109
Elena Chiorean, 206-606-6248, gchiorea@seattlecca.org
Elena Chiorean
- Recruiting
The University of Kansas Cancer Center - Westwood- Site Number : 8400008
Westwood, Kansas, 66205
Lisa Bogart, 913-945-7552, CTNurseNav@kumc.edu
Joaquina Baranda
Chile4 sites, 4 recruiting
- Recruiting
Fundacion Arturo Lopez Perez (FALP) - Providencia - Jose Manuel Infante 805_Investigational Site Number : 1520007
Providencia, 7500000
Christian Caglevic Medina, (562) 242-0509 ext. 8, christian.caglevic@falp.org
Christian Caglevic Medina
- Recruiting
Servicios Médicos URUMED SpA_Investigational Site Number : 1520002
Rancagua, General Bernardo O'Higgins, 2852424
Plinio Fernandez, 56 9 8902 2206, pliniofernandez@urumed.cl
Plinio Fernandez
- Recruiting
BIOCINETIC Ltda_Investigational Site Number : 1520008
Santiago, Reg Metropolitana de Santiago, 8331143
Nicolas Obando Martínez, 569 90790781, nicolas.obando@cecim.cl
Nicolas Obando Martínez
- Recruiting
Centro de Investigacion Clinica Bradford Hill_Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, 8420383
Carlos Ignacio Rojas Garcia, 56 9 9874 4662, cirojas@bh.cl
Carlos Ignacio Rojas Garcia
Israel4 sites, 4 recruiting
- Recruiting
Hadassah Medical Center - PPDS_Investigational Site Number : 3760005
Jerusalem, Jerusalem, 9112001
Jonathan Cohen, 972505172537, cohenjon@hadassah.org.il
Jonathan Cohen
- Recruiting
Sheba Medical Center - PPDS_Investigational Site Number : 3760003
Ramat Gan, 5262100
Tamar Beller, 972545964434, Tamar.Beller@sheba.health.gov.il
Tamar Beller
- Recruiting
Tel Aviv Sourasky Medical Center Ichilov - PPDS_Investigational Site Number : 3760001
Tel Aviv, 6423906
Ravit Geva, 97236973494, ravitg@tlvmc.gov.il
Ravit Geva
- Recruiting
Shamir Medical Center_Investigational Site Number : 3760004
Tzrifin, 7033001
Carmell Fink, 972584882432, carmelf@shamir.gov.il
Carmell Fink
Netherlands2 sites, 2 recruiting
- Recruiting
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis_Investigational Site Number : 5280001
Amsterdam, North Holland, 1066 CX
Marloes van Dongen, 31205129111, mg.v.dongen@nki.nl
Marloes van Dongen
- Recruiting
Erasmus MC_Investigational Site Number : 5280003
Rotterdam, South Holland, 3015 CE
Ferry Eskens, 31107034897, f.eskens@erasmusmc.nl
Ferry Eskens
Spain2 sites, 2 recruiting
- Recruiting
Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON_Investigational Site Number : 7240007
Barcelona, Barcelona [Barcelona], 08035
Elena Garralda, 34932746085, egarralda@vhio.net
Elena Garralda
- Recruiting
START MADRID_Hospital Universitario HM Sanchinarro - CIOCC_Investigational Site Number : 7240005
Madrid, 28050
Emiliano Calvo, 34917567825, emiliano.calvo@startmadrid.com
Emiliano Calvo
Japan1 site
- Active, not recruiting
Investigational Site Number : 3920001
Kashiwa, Chiba, 277-8577
About this study
Official title: A Phase 1/2, Open Label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Solid Tumors
This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with other anticancer therapies for participants aged at least 18 years with advanced unresectable or metastatic solid tumors.
The study will include 2 parts:
Read more
A dose escalation Part 1: for finding the therapeutic dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW) and in combination with other anticancer therapies when applicable.
A multicohort dose expansion/dose optimization Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab or with next generation aCTLA4 (ADG126) or with bevacizumab. 2 recommended doses for expansion/optimization of SAR445877 identified from dose escalation part 1 will be tested in different indications in monotherapy and in combination with other anticancer therapies as applicable.
Approximately 542 participants will be exposed to the study intervention:
- approximately 123 participants in part 1,
- up to 410 participants in expansion/dose optimization part (part 2)
- and up to 9 participants in Japan cohort F.
Read the detailed description
The duration of the study for a participant will include:
- Screening Period: up to 28 days
- Treatment Period: enrolled and exposed participants will receive continuous treatment until progressive disease (PD), or an occurrence of an unacceptable AE, a withdrawal of consent, or until other permanent discontinuation criteria described in the protocol are met.
The End of Treatment (EOT) visit will occur 30 days ±7 days from the last IMP administration or prior to the initiation of further therapy, whichever occurs first.
The follow-up period will occur until disease progression, the start of new anticancer therapy, death, or withdrawal of participant's consent, whichever comes first.
- Conditions
- Solid Tumor
- Being tested
- SAR445877, Cetuximab, ADG126, Bevacizumab, Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR445877Drug
Concentrate for solution for infusion
CetuximabDrug
Also called Erbitux
Solution for infusion
ADG126Drug
Solution for infusion
BevacizumabDrug
Also called bevacizumab-bvzr, Zirabev®
Solution for infusion
NivolumabDrug
Also called Opdivo®
Solution for infusion
IpilimumabDrug
Also called Yervoy®
Solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| SAR445877 Escalation Phase (Part 1A) | Experimental | SAR445877 monotherapy will be administered intravenously in participants with solid tumors over a 14-day cycle. Receives: Drug: SAR445877 |
| SAR445877 Escalation Phase (Part1B) | Experimental | SAR445877 will be administered intravenously in combination with ADG126 in participants with advanced unresectable or metastatic melanoma, non-small cell lung cancer (NSCLC); renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), colorectal cancer (MSIH/dMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC). Receives: Drug: SAR445877; Drug: ADG126 |
| SAR445877 Escalation Phase (Part 1C) | Experimental | SAR445877 will be administered intravenously in combination with bevacizumab in participants with metastatic colorectal cancer (CRC). Receives: Drug: SAR445877; Drug: Bevacizumab |
| SAR445877 Expansion/Optimization Phase: Cohort A1 (Part 2A) | Experimental | SAR445877 monotherapy will be administered intravenously (IV) in participants with non-small cell lung cancer (NSCLC). Receives: Drug: SAR445877 |
| SAR445877 Expansion/Optimization Phase: Cohort A2 (Part 2A) | Experimental | SAR445877 monotherapy will be administered intravenously (IV) in participants with non-small cell lung cancer (NSCLC). Receives: Drug: SAR445877 |
| SAR445877 Expansion/Optimization Phase: Cohort B (Part 2A) | Experimental | SAR445877 monotherapy will be administered intravenously in participants with hepatocellular carcinoma (HCC). Receives: Drug: SAR445877 |
| SAR445877 Expansion/Optimization Phase: Cohort C1 (Part 2A) | Experimental | SAR445877 monotherapy will be administered intravenously in participants with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ). Receives: Drug: SAR445877 |
| SAR445877 Expansion/Optimization Phase: Cohort C2 (Part 2A) | Experimental | SAR445877 monotherapy will be administered intravenously in participants with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ). Receives: Drug: SAR445877 |
| SAR445877 Expansion/Optimization Phase: Cohort D (Part 2A) | Experimental | SAR445877 monotherapy will be administered intravenously IV in participants with immune infiltrated tumor type. Receives: Drug: SAR445877 |
| SAR445877 Expansion/Optimization Phase: Cohort E1 (Part 2B) | Experimental | SAR445877 monotherapy will be administered intravenously in participants with colorectal cancer (CRC). Receives: Drug: SAR445877 |
| SAR445877 Expansion/optimization Phase: Cohort E2 (Part 2A) | Experimental | SAR445877 monotherapy will be administered intravenously in participants with colorectal cancer (CRC). Receives: Drug: SAR445877 |
| SAR445877 Expansion/optimization Phase: Cohort E3 (Part 2B) | Experimental | SAR445877 will be administered intravenously in combination with cetuximab in participants with colorectal cancer. Receives: Drug: SAR445877; Drug: Cetuximab |
| SAR445877 Japan Cohort F | Experimental | SAR445877 monotherapy will be administered intravenously in participants with advanced unresectable or metastatic solid tumor, from Japan. Receives: Drug: SAR445877 |
| SAR445877 Expansion/Optimization Phase Cohort G1 (Part 2C) | Experimental | SAR445877 will be administered intravenously in combination with ADG126 in participants with metastatic melanoma. Receives: Drug: SAR445877; Drug: ADG126 |
| SAR445877 Expansion/Optimization Phase Cohort G2 (Part 2C) | Experimental | SAR445877 will be administered intravenously in combination with ADG126 in participants with metastatic melanoma. Receives: Drug: SAR445877; Drug: ADG126 |
| SAR445877 Expansion/Optimization Phase Cohort G3 (Part 2C) | Experimental | The Standard of Care (nivolumab and ipilimumab) will be administered intravenously in participants with metastatic melanoma. Receives: Drug: Nivolumab; Drug: Ipilimumab |
| SAR445877 Expansion/Optimization Phase Cohort H1 (Part 2D) | Experimental | SAR445877 will be administered intravenously in combination with bevacizumab in participants with advanced unresectable or metastatic CRC. Receives: Drug: SAR445877; Drug: Bevacizumab |
| SAR445877 Expansion/Optimization Phase Cohort H2 (Part 2D) | Experimental | SAR445877 will be administered intravenously in combination with bevacizumab in participants with advanced unresectable or metastatic CRC. Receives: Drug: SAR445877; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation part 1A, 1C and Japan Cohort F: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2
DLTs will be defined using NCI CTCAE version 5.0 or ASTCT criteria for CRS or immune effector cell-associated neurotoxicity syndrome (ICANS)
Measured: Cycles 1 & 2 - 14 days per cycle
Dose escalation part 1B: Presence of dose-limiting toxicities (DLTs) in Cycle 1 to 3 in part B
Measured: Cycle 1 to 3 -14 days per cycle
Dose escalation and Japan Cohort F: Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Presence of TEAEs, SAEs, and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Measured: The time from the first dose of study interventions up to 30 days after last dose of study interventions
Dose expansion/optimization: Objective response rate (ORR)
Proportion of participants who have a confirmed complete response (CR) or a partial response (PR), as the best overall response (BOR) determined by the Investigator as per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: From baseline to the end of dose expansion/optimization (up to 2 years)
Secondary outcomes (13)
Dose escalation and Japan Cohort F: Objective response rate (ORR)
Proportion of participants who have a confirmed complete response (CR) or a partial response (PR), as the best overall response (BOR) determined by the Investigator as per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: From baseline to the end of dose escalation (up to 2 years)
Dose escalation, expansion/optimization and Japan Cohort F: Duration of response (DoR)
DoR is defined as the time from first documented evidence of confirmed CR or PR until progressive disease (PD) determined by Investigator per RECIST 1.1 or death from any cause, whichever occurs first
Measured: From baseline to the end of study (up to 2 years)
Dose escalation, expansion/optimization and Japan Cohort F: Assessment of SAR445877 Cmax
Maximum plasma concentration observed
Measured: Cycle 1 Day 1 to Day 8 or Day 14 (cycle duration of 14 days)
Dose escalation, expansion/optimization and Japan Cohort F: Assessment of SAR445877 AUCtau
Area under the concentration versus time curve calculated using the trapezoidal method during a dosing interval (T)
Measured: Cycle 1 Day 1 to Day 8 or Day 14 (cycle duration of 14 days)
Dose escalation, expansion/optimization and Japan Cohort F: Assessment of SAR445877 Tmax
First time to reach Cmax
Measured: Cycle 1 Day 1 to Day 8 or Day 14 (cycle duration of 14 days)
Dose escalation, expansion/optimization in Combination: Assessment of combined therapies Ctrough
Measured: Day 1 of each cycle to cycle 4 (cycle duration of 14 days)
Dose escalation, expansion/optimization and Japan Cohort F: Percentage of participants with presence of anti-drug antibodies (ADAs) against SAR445877
Measured: From the first dose of Cycle 1 to 30 days after last dose of study interventions (cycle duration of 14 days)
Dose escalation, expansion/optimization: Percentage of participants with presence of anti-drug antibodies (ADAs) against ADG126
Measured: From the first dose of Cycle 1 to 30 days after last dose of study interventions (cycle duration of 14 days)
Dose expansion/optimization: Time to response
Time to response is defined as the time from the first administration of investigational medicinal product (IMP) to the first documented evidence of confirmed PR or CR determined by Investigator per RECIST 1.1
Measured: From baseline to end of dose expansion/optimization (up to 2 years)
Dose expansion/optimization: Clinical Benefit Rate
Clinical Benefit Rate including confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by Investigator per RECIST 1.1
Measured: From baseline to end of dose expansion/optimization (up to 2 years)
Dose expansion/optimization: Progression-free survival
PFS is defined as the time from the date of first administration of IMP to the date of the first documented disease progression determined by Investigator as per RECIST 1.1 or death from any cause, whichever occurs first
Measured: From baseline to end of dose expansion/optimization (up to 2 years)
Dose expansion/optimization: Overall survival
Overall survival (OS) is defined as the time from the first dose of IMP to the date of death due to any cause.
Measured: From baseline to end of dose expansion/optimization (up to 2 years)
Dose expansion/optimization: Number of participants with Adverse events (AE)
Presence of adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Measured: The time from the first dose of study interventions up to 30 days after last dose of study interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start29 Nov 2022
- Primary completion19 Jan 2027 (estimated)
- Study completion28 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 542 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584670
- Sponsor's protocol ID
- TCD17620
- Other IDs
- U1111-1277-4827, 2023-507141-28, 2022-001239-95, 2023
- Status last verified
- Jun 2026
- First submitted
- 7 Oct 2022
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open Label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR445877 Administered as Monotherapy or in Combination With Other Anticancer Therapies in Adults With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05584670
- Acronym / sponsor ID
- TCD17620
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 542 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 19 Jan 2027 (estimated)
- Study completion
- 28 Jun 2028 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1/2, open label, multiple cohort study to assess the safety and preliminary efficacy of SAR445877 as a monotherapy or in combination with other anticancer therapies for participants aged at least 18 years with advanced unresectable or metastatic solid tumors.
The study will include 2 parts:
A dose escalation Part 1: for finding the therapeutic dose(s) of SAR445877 in a monotherapy given every 2 weeks (Q2W) or weekly (QW) and in combination with other anticancer therapies when applicable.
A multicohort dose expansion/dose optimization Part 2: for the assessment of safety and preliminary efficacy of SAR445877 in monotherapy and in combination with cetuximab or with next generation aCTLA4 (ADG126) or with bevacizumab. 2 recommended doses for expansion/optimization of SAR445877 identified from dose escalation part 1 will be tested in different indications in monotherapy and in combination with other anticancer therapies as applicable.
Approximately 542 participants will be exposed to the study intervention:
- approximately 123 participants in part 1,
- up to 410 participants in expansion/dose optimization part (part 2)
- and up to 9 participants in Japan cohort F.
Detailed description
The duration of the study for a participant will include:
- Screening Period: up to 28 days
- Treatment Period: enrolled and exposed participants will receive continuous treatment until progressive disease (PD), or an occurrence of an unacceptable AE, a withdrawal of consent, or until other permanent discontinuation criteria described in the protocol are met.
The End of Treatment (EOT) visit will occur 30 days ±7 days from the last IMP administration or prior to the initiation of further therapy, whichever occurs first.
The follow-up period will occur until disease progression, the start of new anticancer therapy, death, or withdrawal of participant's consent, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| SAR445877 Escalation Phase (Part 1A) | Experimental | Drug: SAR445877SAR445877 monotherapy will be administered intravenously in participants with solid tumors over a 14-day cycle. |
| SAR445877 Escalation Phase (Part1B) | Experimental | Drug: SAR445877, Drug: ADG126SAR445877 will be administered intravenously in combination with ADG126 in participants with advanced unresectable or metastatic melanoma, non-small cell lung cancer (NSCLC); renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), colorectal cancer (MSIH/dMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC). |
| SAR445877 Escalation Phase (Part 1C) | Experimental | Drug: SAR445877, Drug: BevacizumabSAR445877 will be administered intravenously in combination with bevacizumab in participants with metastatic colorectal cancer (CRC). |
| SAR445877 Expansion/Optimization Phase: Cohort A1 (Part 2A) | Experimental | Drug: SAR445877SAR445877 monotherapy will be administered intravenously (IV) in participants with non-small cell lung cancer (NSCLC). |
| SAR445877 Expansion/Optimization Phase: Cohort A2 (Part 2A) | Experimental | Drug: SAR445877SAR445877 monotherapy will be administered intravenously (IV) in participants with non-small cell lung cancer (NSCLC). |
| SAR445877 Expansion/Optimization Phase: Cohort B (Part 2A) | Experimental | Drug: SAR445877SAR445877 monotherapy will be administered intravenously in participants with hepatocellular carcinoma (HCC). |
| SAR445877 Expansion/Optimization Phase: Cohort C1 (Part 2A) | Experimental | Drug: SAR445877SAR445877 monotherapy will be administered intravenously in participants with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ). |
| SAR445877 Expansion/Optimization Phase: Cohort C2 (Part 2A) | Experimental | Drug: SAR445877SAR445877 monotherapy will be administered intravenously in participants with gastric cancer/gastro esophageal junction adenocarcinoma (GC/GEJ). |
| SAR445877 Expansion/Optimization Phase: Cohort D (Part 2A) | Experimental | Drug: SAR445877SAR445877 monotherapy will be administered intravenously IV in participants with immune infiltrated tumor type. |
| SAR445877 Expansion/Optimization Phase: Cohort E1 (Part 2B) | Experimental | Drug: SAR445877SAR445877 monotherapy will be administered intravenously in participants with colorectal cancer (CRC). |
| SAR445877 Expansion/optimization Phase: Cohort E2 (Part 2A) | Experimental | Drug: SAR445877SAR445877 monotherapy will be administered intravenously in participants with colorectal cancer (CRC). |
| SAR445877 Expansion/optimization Phase: Cohort E3 (Part 2B) | Experimental | Drug: SAR445877, Drug: CetuximabSAR445877 will be administered intravenously in combination with cetuximab in participants with colorectal cancer. |
| SAR445877 Japan Cohort F | Experimental | Drug: SAR445877SAR445877 monotherapy will be administered intravenously in participants with advanced unresectable or metastatic solid tumor, from Japan. |
| SAR445877 Expansion/Optimization Phase Cohort G1 (Part 2C) | Experimental | Drug: SAR445877, Drug: ADG126SAR445877 will be administered intravenously in combination with ADG126 in participants with metastatic melanoma. |
| SAR445877 Expansion/Optimization Phase Cohort G2 (Part 2C) | Experimental | Drug: SAR445877, Drug: ADG126SAR445877 will be administered intravenously in combination with ADG126 in participants with metastatic melanoma. |
| SAR445877 Expansion/Optimization Phase Cohort G3 (Part 2C) | Experimental | Drug: Nivolumab, Drug: IpilimumabThe Standard of Care (nivolumab and ipilimumab) will be administered intravenously in participants with metastatic melanoma. |
| SAR445877 Expansion/Optimization Phase Cohort H1 (Part 2D) | Experimental | Drug: SAR445877, Drug: BevacizumabSAR445877 will be administered intravenously in combination with bevacizumab in participants with advanced unresectable or metastatic CRC. |
| SAR445877 Expansion/Optimization Phase Cohort H2 (Part 2D) | Experimental | Drug: SAR445877, Drug: BevacizumabSAR445877 will be administered intravenously in combination with bevacizumab in participants with advanced unresectable or metastatic CRC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Dose escalation Part 1A and Japan Cohort F
- Dose escalation Part 1B
- Dose escalation Part 1C
- Dose expansion/optimization Part 2
- Participants must have MSI status known or determined locally and must have non- MSI-H disease to be eligible.
Key exclusion criteria (14 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
- Predicted life expectancy ≤3 months
- For participants with HCC- Cohort B (Part 2): Child Pugh Class B or C liver score. Participants with Child Pugh Class B-7 score are allowed for Part 1.
- Diagnosed of any other malignancies, either progressing or requiring active treatments, within 2 years prior to enrollment
- Known active brain metastases or leptomeningeal metastases
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 |
|---|---|---|
| SAR445877Concentrate for solution for infusion | Drug | SAR445877 Escalation Phase (Part 1A), SAR445877 Escalation Phase (Part 1C), SAR445877 Escalation Phase (Part1B), SAR445877 Expansion/Optimization Phase Cohort G1 (Part 2C), SAR445877 Expansion/Optimization Phase Cohort G2 (Part 2C), SAR445877 Expansion/Optimization Phase Cohort H1 (Part 2D), SAR445877 Expansion/Optimization Phase Cohort H2 (Part 2D), SAR445877 Expansion/Optimization Phase: Cohort A1 (Part 2A), SAR445877 Expansion/Optimization Phase: Cohort A2 (Part 2A), SAR445877 Expansion/Optimization Phase: Cohort B (Part 2A), SAR445877 Expansion/Optimization Phase: Cohort C1 (Part 2A), SAR445877 Expansion/Optimization Phase: Cohort C2 (Part 2A), SAR445877 Expansion/Optimization Phase: Cohort D (Part 2A), SAR445877 Expansion/Optimization Phase: Cohort E1 (Part 2B), SAR445877 Expansion/optimization Phase: Cohort E2 (Part 2A), SAR445877 Expansion/optimization Phase: Cohort E3 (Part 2B), SAR445877 Japan Cohort F |
| CetuximabAlso: ErbituxSolution for infusion | Drug | SAR445877 Expansion/optimization Phase: Cohort E3 (Part 2B) |
| ADG126Solution for infusion | Drug | SAR445877 Escalation Phase (Part1B), SAR445877 Expansion/Optimization Phase Cohort G1 (Part 2C), SAR445877 Expansion/Optimization Phase Cohort G2 (Part 2C) |
| BevacizumabAlso: bevacizumab-bvzr, Zirabev®Solution for infusion | Drug | SAR445877 Escalation Phase (Part 1C), SAR445877 Expansion/Optimization Phase Cohort H1 (Part 2D), SAR445877 Expansion/Optimization Phase Cohort H2 (Part 2D) |
| NivolumabAlso: Opdivo®Solution for infusion | Drug | SAR445877 Expansion/Optimization Phase Cohort G3 (Part 2C) |
| IpilimumabAlso: Yervoy®Solution for infusion | Drug | SAR445877 Expansion/Optimization Phase Cohort G3 (Part 2C) |
Primary outcome
Dose escalation part 1A, 1C and Japan Cohort F: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2
Time frame: Cycles 1 & 2 - 14 days per cycle
DLTs will be defined using NCI CTCAE version 5.0 or ASTCT criteria for CRS or immune effector cell-associated neurotoxicity syndrome (ICANS)
Dose escalation part 1B: Presence of dose-limiting toxicities (DLTs) in Cycle 1 to 3 in part B
Time frame: Cycle 1 to 3 -14 days per cycle
Dose escalation and Japan Cohort F: Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Time frame: The time from the first dose of study interventions up to 30 days after last dose of study interventions
Presence of TEAEs, SAEs, and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Dose expansion/optimization: Objective response rate (ORR)
Time frame: From baseline to the end of dose expansion/optimization (up to 2 years)
Proportion of participants who have a confirmed complete response (CR) or a partial response (PR), as the best overall response (BOR) determined by the Investigator as per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
13 secondary outcomes
Dose escalation and Japan Cohort F: Objective response rate (ORR)
Time frame: From baseline to the end of dose escalation (up to 2 years)
Dose escalation, expansion/optimization and Japan Cohort F: Duration of response (DoR)
Time frame: From baseline to the end of study (up to 2 years)
Dose escalation, expansion/optimization and Japan Cohort F: Assessment of SAR445877 Cmax
Time frame: Cycle 1 Day 1 to Day 8 or Day 14 (cycle duration of 14 days)
Dose escalation, expansion/optimization and Japan Cohort F: Assessment of SAR445877 AUCtau
Time frame: Cycle 1 Day 1 to Day 8 or Day 14 (cycle duration of 14 days)
Dose escalation, expansion/optimization and Japan Cohort F: Assessment of SAR445877 Tmax
Time frame: Cycle 1 Day 1 to Day 8 or Day 14 (cycle duration of 14 days)
Dose escalation, expansion/optimization in Combination: Assessment of combined therapies Ctrough
Time frame: Day 1 of each cycle to cycle 4 (cycle duration of 14 days)
Dose escalation, expansion/optimization and Japan Cohort F: Percentage of participants with presence of anti-drug antibodies (ADAs) against SAR445877
Time frame: From the first dose of Cycle 1 to 30 days after last dose of study interventions (cycle duration of 14 days)
Dose escalation, expansion/optimization: Percentage of participants with presence of anti-drug antibodies (ADAs) against ADG126
Time frame: From the first dose of Cycle 1 to 30 days after last dose of study interventions (cycle duration of 14 days)
Dose expansion/optimization: Time to response
Time frame: From baseline to end of dose expansion/optimization (up to 2 years)
Dose expansion/optimization: Clinical Benefit Rate
Time frame: From baseline to end of dose expansion/optimization (up to 2 years)
Dose expansion/optimization: Progression-free survival
Time frame: From baseline to end of dose expansion/optimization (up to 2 years)
Dose expansion/optimization: Overall survival
Time frame: From baseline to end of dose expansion/optimization (up to 2 years)
Dose expansion/optimization: Number of participants with Adverse events (AE)
Time frame: The time from the first dose of study interventions up to 30 days after last dose of study interventions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- TCD17620 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
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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.
Trial Transparency email recommended (Toll free for US & Canada) contact
Clinical Sciences & Operations study director
Sanofi
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SAR445877, Cetuximab and ADG126 in people with Solid Tumor, run by Sanofi at 22 sites in 6 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 33 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Chile, Israel, Netherlands, Spain and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose escalation part 1A, 1C and Japan Cohort F: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2 (time frame: Cycles 1 & 2 - 14 days per cycle). The study lists 4 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 23 Jun 2026.