A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
9 states
Healthy volunteers
No
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About this study
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.
Sponsor: Sanofi
You may qualify if…
- ✓ 1. 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
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Newark
Iowa City
Westwood
Detroit
Hackensack
New York
Providence
Houston
Seattle
Source: ClinicalTrials.gov · NCT05584670 · last updated 2026-06-23