Non-small Cell Lung CancerPhase 1/2NCT05709821
IMM60 and Pembrolizumab in Melanoma and NSCLC
A Phase 1/2 study testing IMM60 and Pembrolizumab in people with Non-small Cell Lung Cancer and Melanoma, run by iOx Therapeutics at 14 sites in 3 countries.
Trial summary
The goal of this clinical trial is to learn about IMM60 with or without pembrolizumab in participants with advanced melanoma or non-small cell lung cancer. There are two phases: Phase 1: This phase is designed to learn about the safety of IMM60 with or without pembrolizumab and to find a safe dose to test in Phase 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Melanoma
- What is being tested?
- IMM60 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 15 Nov 2023to 22 Apr 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 to 1
- Adequate organ function
- At least 1 lesion, not previously irradiated, that can be accurately measured on CT or MRI as defined by RECIST 1.1 criteria
- NSCLC cohorts: Histologically confirmed diagnosis of stage IV NSCLC
- NSCLC cohorts: Patients with adenocarcinoma histology must not have sensitizing epidermal growth factor receptor (EGFR) or ROS proto-oncogene 1 (ROS1) mutations or anaplastic lymphoma kinase (ALK) translocations
- NSCLC cohorts: Participants in NSCLC arms must have a PD-L1 assessment (PD-L1 immuno-histochemistry (IHC) 22C3 pharmDx)
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- Melanoma cohorts: Unresectable stage III or IV, histologically confirmed diagnosis of cutaneous or unknown primary melanoma
- Melanoma cohorts: B-type Raf proto-oncogene (BRAF) mutation status available
- Male participants: Participant must agree to use contraception and refrain from sperm donation during the treatment period and for at least 120 days after the last dose of study intervention
- Female participants: Participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP)
- A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 6 months after the last dose of study intervention
Who cannot join
- Has the following cardiac conditions:
- Corrected QT interval (QTc) > 450 ms
- Uncontrolled hypertension with blood pressure (BP) > 160/100 despite treatment
- Class II or greater heart failure as defined by the New York Heart Association
- Myocardial infarction within 6 months or angina requiring nitrate therapy more than once a week
- Another active malignancy within the past 2 years (Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded. Also, prostate, breast, and neuroendocrine tumors that are stable on hormonal treatment for a period of 1 year or more without the need to adjust dose are not excluded.)
Show all 11Show fewer
- Has had an allogeneic tissue/solid organ transplant
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Participants with an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids (in dosing exceeding 10 mg daily of prednisone equivalent) or immunosuppressive agents.
- Participants who are known to be serologically positive for Hepatitis B, Hepatitis C, or human immunodeficiency virus.
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Spain8 sites
Complexo Hospitalario Universitario A Coruña
A Coruña, Galicia, 15006
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Regional Universitario de Málaga
Málaga, 29011
Hospital Universitario Virgen De La Macarena
Seville, 41009
H. Clínico de Valencia
Valencia, 46010
Hospital Xeral Álvaro Cunqueiro
Vigo, Pontevedra, 36312
United States5 sites
Dana-Farber Cancer Institute - Medicine
Boston, Massachusetts, 02215
Henry Ford Hospital - Internal Medicine
Detroit, Michigan, 48202
Next VA
Fairfax, Virginia, 22031
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Rutgers, The State University of New Jersey - Robert Wood Johnson Medical School - The Cancer Institute of New Jersey (CINJ)
New Brunswick, New Jersey, 08901
United Kingdom1 site
Nottingham University Hospital - Oncology
Nottingham, NG5 1PB
About this study
Official title: IMPORT-201: A Phase 1 First-in-Human Dose Finding/Randomized Phase 2 Study of IMM60 and Pembrolizumab for Advanced Melanoma and Metastatic NSCLC
The goal of this clinical trial is to learn about IMM60 with or without pembrolizumab in participants with advanced melanoma or non-small cell lung cancer. There are two phases:
- Phase 1: This phase is designed to learn about the safety of IMM60 with or without pembrolizumab and to find a safe dose to test in Phase 2.
- Phase 2: This phase is designed to learn whether IMM60 + pembrolizumab improves progression-free survival at 12 months compared to pembrolizumab alone in participants with non-small cell lung cancer.
Read the detailed description
This exploratory phase 1/phase 2 study is designed to establish a recommended phase 2 dose of IMM60 and provide preliminary estimates of safety and efficacy of IMM60 alone and in combination with pembrolizumab in participants with NSCLC and melanoma. In phase 1, initial safety will be assessed in a multiple dose escalation cohort for IMM60 alone, then for the IMM60 + pembrolizumab combination. Phase 2 of the study will recruit PD-1 pretreated melanoma participants and randomize PD-L1 > 50% total NSCLC participants 2:1 to IMM60 + pembrolizumab vs pembrolizumab alone. There is an additional cohort of PD-L1 < 1% NSCLC participants.
- Conditions
- Non-small Cell Lung Cancer, Melanoma
- Being tested
- IMM60, Pembrolizumab
- Keywords
- Invariant natural killer T cells (iNKT), Programmed Cell Death-1 (PD1, PD-1)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM60Drug
Also called PORT-2
IMM60, every 3 weeks for up to 6 cycles, intravenous (IV) infusion
PembrolizumabDrug
Also called KEYTRUDA®
Pembrolizumab, 200 mg, every 3 weeks for up to 35 cycles or approximately 2 years, intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 IMM60 dose escalation safety arm | Experimental | 3 dose levels of IMM60 will be assessed (1, 3, 9 and 36 mg/m^2 administered IV every 3 weeks for up to 6 cycles) Receives: Drug: IMM60 |
| Phase 1 IMM60 + pembrolizumab combination safety arm | Experimental | Pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles will be administered in combination with IMM60 IV every 3 weeks for up to 6 cycles. The IMM60 dose will be determined based on the results of the IMM60 dose escalation safety cohort. Receives: Drug: IMM60; Drug: Pembrolizumab |
| Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, IMM60 + pembrolizumab) | Experimental | Pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles will be administered in combination with IMM60 IV every 3 weeks for up to 6 cycles. The IMM60 dose will be determined based on the results of the Phase 1 dose escalation safety cohorts. Receives: Drug: IMM60; Drug: Pembrolizumab |
| Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, pembrolizumab monotherapy) | Active comparator | Pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles. Receives: Drug: Pembrolizumab |
| Phase 2 PD-L1 <1% NSCLC Cohort 2 | Experimental | Participants will be treated with one cycle of IMM60 with a tumor biopsy before and after, to determine any changes in PD-L1 expression. After this one cycle, the participants will receive the combination of IMM60 IV for up to 6 total cycles + pembrolizumab 200 mg every 3 weeks administered IV. The IMM60 dose will be determined based on the results of the Phase 1 dose escalation cohorts. Receives: Drug: IMM60; Drug: Pembrolizumab |
| Melanoma Cohort | Experimental | IMM60 IV every 3 weeks for up to 6 cycles. The IMM60 dose will be determined based on the results of the Phase 1 dose escalation cohorts. Receives: Drug: IMM60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Co-Primary Objective - Identify Maximum Tolerated Dose (MTD)
To confirm the maximum tolerated dose (MTD) of IMM60 alone and in combination with pembrolizumab, defined as the highest dose level at which <2 out of 6 participants experience a dose-limiting toxicity
Measured: Assessed at the end of Cycle 1 for each patient (each Cycle is 28 days)
Phase 1 Co-Primary Objective - Safety
To characterize the safety of IMM60 alone and in combination with pembrolizumab, as assessed by the frequency of Grade 3 or higher treatment-related adverse events
Measured: Through Phase 1 completion, an average of 1 year
Phase 2 Primary Objective - Progression-free Survival
To compare the progression-free survival (PFS) rate at 12 months in the randomized arms comparing pembrolizumab alone versus IMM60 + pembrolizumab in patients with advanced PD-L1 ≥50% NSCLC
Measured: 12 months after last participant enrolled
Secondary outcomes (7)
To characterize the safety of IMM60 alone or in combination with pembrolizumab
Frequency and severity of treatment-related adverse events (AEs)
Measured: Through study completion, an average of 3 years
To determine if IMM60 can restore sensitivity in PD-1 inhibitor-resistant melanoma (phase 2)
Objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in melanoma patients who have progressed on PD-1, and have added IMM60
Measured: 12 months after last participant enrolled
Pharmacokinetics of IMM60 - Cmax (IMM60 arms only)
IMM60 maximal concentration (Cmax)
Measured: During Cycles 1 and 3 (each Cycle is 28 days)
Pharmacokinetics of IMM60 - AUC (IMM60 arms only)
IMM60 area under the curve (AUC)
Measured: During Cycles 1 and 3 (each Cycle is 28 days)
Objective Response Rate (ORR)
ORR is to be reported as the proportion of patients who have a Complete Response or Partial Response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Measured: 12 months after last participant enrolled
To determine if IMM60 can sensitize patients with programmed death-ligand 1 (PD-L1) <1% NSCLC to PD-1 inhibition
Objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in PDL1 <1% NSCLC patients who receive IMM60 + pembrolizumab
Measured: 12 months after last participant enrolled
To assess the ability of IMM60 to convert PD-L1 negative patients to PD-L1 positive
Percent of PD-L1 negative (<1%) NSCLC tumors that increase PD-L1 gene expression following treatment with IMM60
Measured: 12 months after last participant enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start15 Nov 2023
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Why it stopped: Prioritization of other pipeline assets. No safety or efficacy issues were observed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOx Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709821
- Sponsor's protocol ID
- IMPORT-201
- Other IDs
- KEYNOTE-E69, 2022-003310-36
- Status last verified
- Apr 2024
- First submitted
- 6 Jan 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPORT-201: A Phase 1 First-in-Human Dose Finding/Randomized Phase 2 Study of IMM60 and Pembrolizumab for Advanced Melanoma and Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT05709821
- Acronym / sponsor ID
- IMPORT-201
- Conditions
- Non-small Cell Lung Cancer, Melanoma
- Keywords
- Invariant natural killer T cells (iNKT), Programmed Cell Death-1 (PD1, PD-1)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Prioritization of other pipeline assets. No safety or efficacy issues were observed.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- iOx TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 2 Feb 2023 (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.
The goal of this clinical trial is to learn about IMM60 with or without pembrolizumab in participants with advanced melanoma or non-small cell lung cancer. There are two phases:
- Phase 1: This phase is designed to learn about the safety of IMM60 with or without pembrolizumab and to find a safe dose to test in Phase 2.
- Phase 2: This phase is designed to learn whether IMM60 + pembrolizumab improves progression-free survival at 12 months compared to pembrolizumab alone in participants with non-small cell lung cancer.
Detailed description
This exploratory phase 1/phase 2 study is designed to establish a recommended phase 2 dose of IMM60 and provide preliminary estimates of safety and efficacy of IMM60 alone and in combination with pembrolizumab in participants with NSCLC and melanoma. In phase 1, initial safety will be assessed in a multiple dose escalation cohort for IMM60 alone, then for the IMM60 + pembrolizumab combination. Phase 2 of the study will recruit PD-1 pretreated melanoma participants and randomize PD-L1 > 50% total NSCLC participants 2:1 to IMM60 + pembrolizumab vs pembrolizumab alone. There is an additional cohort of PD-L1 < 1% NSCLC participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase 1 IMM60 dose escalation safety arm | Experimental | Drug: IMM603 dose levels of IMM60 will be assessed (1, 3, 9 and 36 mg/m^2 administered IV every 3 weeks for up to 6 cycles) |
| Phase 1 IMM60 + pembrolizumab combination safety arm | Experimental | Drug: IMM60, Drug: PembrolizumabPembrolizumab 200 mg IV every 3 weeks for up to 35 cycles will be administered in combination with IMM60 IV every 3 weeks for up to 6 cycles. The IMM60 dose will be determined based on the results of the IMM60 dose escalation safety cohort. |
| Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, IMM60 + pembrolizumab) | Experimental | Drug: IMM60, Drug: PembrolizumabPembrolizumab 200 mg IV every 3 weeks for up to 35 cycles will be administered in combination with IMM60 IV every 3 weeks for up to 6 cycles. The IMM60 dose will be determined based on the results of the Phase 1 dose escalation safety cohorts. |
| Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, pembrolizumab monotherapy) | Active comparator | Drug: PembrolizumabPembrolizumab 200 mg IV every 3 weeks for up to 35 cycles. |
| Phase 2 PD-L1 <1% NSCLC Cohort 2 | Experimental | Drug: IMM60, Drug: PembrolizumabParticipants will be treated with one cycle of IMM60 with a tumor biopsy before and after, to determine any changes in PD-L1 expression. After this one cycle, the participants will receive the combination of IMM60 IV for up to 6 total cycles + pembrolizumab 200 mg every 3 weeks administered IV. The IMM60 dose will be determined based on the results of the Phase 1 dose escalation cohorts. |
| Melanoma Cohort | Experimental | Drug: IMM60IMM60 IV every 3 weeks for up to 6 cycles. The IMM60 dose will be determined based on the results of the Phase 1 dose escalation cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 to 1
- Adequate organ function
- At least 1 lesion, not previously irradiated, that can be accurately measured on CT or MRI as defined by RECIST 1.1 criteria
- NSCLC cohorts: Histologically confirmed diagnosis of stage IV NSCLC
- NSCLC cohorts: Patients with adenocarcinoma histology must not have sensitizing epidermal growth factor receptor (EGFR) or ROS proto-oncogene 1 (ROS1) mutations or anaplastic lymphoma kinase (ALK) translocations
Key exclusion criteria (11 listed)
- Has the following cardiac conditions:
- Another active malignancy within the past 2 years (Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded. Also, prostate, breast, and neuroendocrine tumors that are stable on hormonal treatment for a period of 1 year or more without the need to adjust dose are not excluded.)
- Has had an allogeneic tissue/solid organ transplant
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
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 |
|---|---|---|
| IMM60Also: PORT-2IMM60, every 3 weeks for up to 6 cycles, intravenous (IV) infusion | Drug | Melanoma Cohort, Phase 1 IMM60 + pembrolizumab combination safety arm, Phase 1 IMM60 dose escalation safety arm, Phase 2 PD-L1 <1% NSCLC Cohort 2, Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, IMM60 + pembrolizumab) |
| PembrolizumabAlso: KEYTRUDA®Pembrolizumab, 200 mg, every 3 weeks for up to 35 cycles or approximately 2 years, intravenous (IV) infusion | Drug | Phase 1 IMM60 + pembrolizumab combination safety arm, Phase 2 PD-L1 <1% NSCLC Cohort 2, Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, IMM60 + pembrolizumab), Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, pembrolizumab monotherapy) |
Primary outcome
Phase 1 Co-Primary Objective - Identify Maximum Tolerated Dose (MTD)
Time frame: Assessed at the end of Cycle 1 for each patient (each Cycle is 28 days)
To confirm the maximum tolerated dose (MTD) of IMM60 alone and in combination with pembrolizumab, defined as the highest dose level at which <2 out of 6 participants experience a dose-limiting toxicity
Phase 1 Co-Primary Objective - Safety
Time frame: Through Phase 1 completion, an average of 1 year
To characterize the safety of IMM60 alone and in combination with pembrolizumab, as assessed by the frequency of Grade 3 or higher treatment-related adverse events
Phase 2 Primary Objective - Progression-free Survival
Time frame: 12 months after last participant enrolled
To compare the progression-free survival (PFS) rate at 12 months in the randomized arms comparing pembrolizumab alone versus IMM60 + pembrolizumab in patients with advanced PD-L1 ≥50% NSCLC
7 secondary outcomes
To characterize the safety of IMM60 alone or in combination with pembrolizumab
Time frame: Through study completion, an average of 3 years
To determine if IMM60 can restore sensitivity in PD-1 inhibitor-resistant melanoma (phase 2)
Time frame: 12 months after last participant enrolled
Pharmacokinetics of IMM60 - Cmax (IMM60 arms only)
Time frame: During Cycles 1 and 3 (each Cycle is 28 days)
Pharmacokinetics of IMM60 - AUC (IMM60 arms only)
Time frame: During Cycles 1 and 3 (each Cycle is 28 days)
Objective Response Rate (ORR)
Time frame: 12 months after last participant enrolled
To determine if IMM60 can sensitize patients with programmed death-ligand 1 (PD-L1) <1% NSCLC to PD-1 inhibition
Time frame: 12 months after last participant enrolled
To assess the ability of IMM60 to convert PD-L1 negative patients to PD-L1 positive
Time frame: 12 months after last participant enrolled
Results and safety
The study was stopped early (reason given: Prioritization of other pipeline assets. No safety or efficacy issues were observed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMM60 and Pembrolizumab in people with Non-small Cell Lung Cancer and Melanoma, run by iOx Therapeutics at 14 sites in 3 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 12 inclusion and 11 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 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, United States, United Kingdom. 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?
The study was stopped early (reason given: Prioritization of other pipeline assets. No safety or efficacy issues were observed.). Results are not available in the source record.
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?
Phase 1 Co-Primary Objective - Identify Maximum Tolerated Dose (MTD) (time frame: Assessed at the end of Cycle 1 for each patient (each Cycle is 28 days)). The study lists 3 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 24 Apr 2024.