SAR445877 for Advanced Solid Tumors
This study is testing SAR445877, alone or with other cancer treatments like Cetuximab, ADG126, Bevacizumab, or Nivolumab, for adults with advanced solid tumors that cannot be removed by surgery or have spread. The main goal is to find a safe dose of SAR445877 and see how well it works. Researchers will be looking for side effects and how the tumor responds. You might be able to join if you have an advanced solid tumor and standard treatments are not available or suitable for you. The study plans to enroll up to 542 participants.
- Study design
- This is a Phase 1/2, open-label study, meaning both you and your doctors will know which treatment you are receiving. It involves multiple groups of participants to find the best dose and then to assess safety and effectiveness.
- What's involved
- You will have a screening period of up to 28 days. If you join, you will receive continuous treatment until your disease gets worse, you have too many side effects, or you decide to stop. There will be a final visit about 30 days after your last treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you will be followed until your disease progresses, you start a new cancer treatment, you pass away, or you withdraw your consent.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05584670
A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentSanofi
~542 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:SAR445877CetuximabADG126BevacizumabNivolumabIpilimumab
At a glance
Recruiting sites
21 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose escalation part 1A, 1C and Japan Cohort F: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2
Measured over Cycles 1 & 2 - 14 days per cycle
+3 more outcomes measured
Conditions
Where it's being run
22 sites across 19 statesIsrael3
Reg Metropolitana de Santiago2
Delaware1
Iowa1
Kansas1
Michigan1
New Jersey1
New York1
Study leadership
- Clinical Sciences & Operations · STUDY_DIRECTOR · Sanofi
Who to contact
Trial Transparency email recommended (Toll free for US & Canada)
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 2. 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. 3. Dose escalation Part 1C
Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer
Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment. 4. Dose expansion/optimization Part 2
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 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 5. 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.
At least 1 measurable lesion per RECIST 1.1 criteria
Exclusion
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
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
What this trial measures
- Dose escalation part 1A, 1C and Japan Cohort F: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2Cycles 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 BCycle 1 to 3 -14 days per cycle
- Dose escalation and Japan Cohort F: Percentage of participants experiencing treatment-emergent adverse events (TEAEs)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)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