A Phase 1/2, open label, first-in-human, dose escalation and expansion study for the evaluation of safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of SAR445877 administered as monotherapy or in combination with other anticancer therapies in adults with advanced solid tumors

Sanofi-Aventis Recherche & Developpement4 个研究点分布在 2 个国家目标入组 115 人2024年10月23日

概览

阶段: 1/2 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Sanofi-Aventis Recherche & Developpement
入组人数: 115
试验地点: 4
主要终点: Dose escalation and Japan Cohort F: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2
状态: 尚未招募
最后更新: 10个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Dose escalation: To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD), recommended dose(s), and the overall safety and tolerability profile of SAR445877 when administered as monotherapy or in combination Japan Cohort F: To confirm the tolerability of SAR445877 in Japanese participants

Dose expansion/optimization: To determine the objective response rate (ORR) of SAR445877 administered as monotherapy or in combination at the recommended dose(s)

注册库

euclinicaltrials.eu

开始日期

2024年10月23日

结束日期

待定

最后更新

10个月前

研究者

发起方

Sanofi-Aventis Recherche & Developpement

责任方

Principal Investigator

主要研究者

Clinical Sciences and Operations

Scientific

Sanofi-Aventis Research & Development

入排标准

入选标准

•Dose escalation Part 1 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
•Dose expansion/optimization Part 2 Cancer diagnosis:For participants in Cohorts C1 and C2: Participants must have MSI or MMR status known or determined locally and must have non-MSI-H or proficient MMR (pMMR) disease to be eligible.
•Dose expansion/optimization Part 2 Cancer diagnosis:For participants in Cohorts C1 and C2: 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.
•Measurable Disease: At least 1 measurable lesion per RECIST 1.1 criteria.
•NOTE: Other Inclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
•Participants in Cohorts E1, E2 and E3: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic colorectal cancer
•Participants must have MSI status known or determined locally and must have non-MSI-H disease to be eligible.
•Dose expansion/optimization Part 2 Cancer diagnosis:For participants in Cohorts C1 and C2: Disease with any CPS scoring. No need for CPS determination at local laboratory).
•Participants with RAS-mutant and BRAF-mutant colorectal cancer are eligible for enrollment.
•Capable of giving signed informed consent.

排除标准

•Eastern Cooperative Oncology Group (ECOG) performance status of ≥
•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
•NOTE: Other Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
•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
•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 ≤

结局指标

主要结局

Dose escalation and Japan Cohort F: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2

Dose escalation and Japan Cohort F: Percentage of participants experiencing treatment-emergent adverse events (TEAEs)

Dose expansion/optimization: Objective response rate (ORR)

次要结局

Dose expansion/optimization Clinical Benefit Rate
Dose escalation and Japan Cohort F Objective response rate (ORR)
Dose escalation, expansion/optimization and Japan Cohort F Duration of response (DoR)
Dose escalation, expansion/optimization and Japan Cohort F Assessment of SAR445877 Cmax
Dose escalation, expansion/optimization and Japan Cohort F Assessment of SAR445877 AUClast
Dose escalation, expansion/optimization and Japan Cohort F Assessment of SAR445877 Tmax
Part 2b Combination Assessment of Cetuximab serum concentration
Dose escalation, expansion/optimization and Japan Cohort F Percentage of participants with presence of anti-drug antibodies (ADAs) to SAR445877
Dose expansion/optimization Time to response
Dose expansion/optimization Progression-free survival
Dose expansion/optimization Number of participants with Adverse events (AE)
Dose expansion/optimization Overall survival