A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participa
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 escal
| Condition(s) | Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. 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 |
| Who can participate | Inclusion Criteria: 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 c |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Sanofi |
| Locations | Newark, Delaware, United States; Iowa City, Iowa, United States; Fairway, Kansas, United States; Detroit, Michigan, United States; Hackensack, New Jersey, United States; New York, New York, United States (+16 more sites) |
| Start date | 2022-11-29 |
| NCT ID | NCT05584670 |
| Official listing | https://clinicaltrials.gov/study/NCT05584670 |