進行固形腫瘍の成人被験者を対象としたSAR445877のヒト初投与、用量漸増および用量拡大試験
基本情報
- NCT ID
- NCT05584670
- ステータス
- 募集中
- 試験のフェーズ
- 第1/第2相
- 試験タイプ
- 介入
- 目標被験者数
- 542
- 治験依頼者名
- Sanofi
概要
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.