Safety and Efficacy Study of SAR442720 in Combination With Pembrolizumab in Advanced Malignancies

• Status: Recruiting
• Trial end date: 2025-07-15
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

Part 1:

• To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in patients with advanced solid tumors including NSCLC who progressed on anti-PD-1/PD L1 containing therapy and advanced colorectal cancer (CRC) after progression to all standard of care (SOC) therapy.

• To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in patients with solid tumors

Part 2:

• To determine the antitumor activity of SAR442720 in combination with pembrolizumab

Secondary Objective:

Part 1:

• To document the pharmacokinetic (PK) of SAR442720 in combination with pembrolizumab and to document the PK of pembrolizumab in combination with SAR442720

• To estimate the anti-tumor effects of SAR442720 in combination with pembrolizumab in all participants

Part 2:

• To assess the safety profile of SAR442720 in combination with pembrolizumab

• To assess other indicators of antitumor activity.

• To assess the pharmacokinetic (PK) of SAR442720 in combination with pembrolizumab, and to assess the PK of pembrolizumab in combination with SAR442720

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Revolution Medicines, Inc.
• Treatments: Pembrolizumab

Criteria

Inclusion criteria :

• Participants must be ≥ 18 years of age

• Histologically proven diagnosis of advanced solid tumors

• Participants must have one or more of the following molecular aberrations (Part 1):

KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations

• At least 1 measurable disease per RECIST 1.1 criteria.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Woman of childbearing potential must agree to follow contraceptive guidance

• Capable of giving signed informed consent

Exclusion criteria:

• Predicted life expectancy <3 months.

• Primary central nervous system (CNS) tumors.

• Symptomatic or impending cord compression.

• History of cerebrovascular stroke or transient ischemic attack within previous 6 months.

• Prior solid organ or hematologic transplant.

• History or current retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vascular occlusion (RVO), neovascular macular degeneration

• Any clinically significant cardiac disease

• Active, known or suspected autoimmune disease

• History of or current interstitial lung disease or pneumonitis

• Receipt of a live-virus vaccination within 28 days of planned treatment start

• Known infection with human immunodeficiency virus (HIV), known uncontrolled hepatitis B infection, active tuberculosis, or severe infection requiring parenteral antibiotic treatment.

• Inadequate hematologic, hepatic and renal function

• Known second malignancy

• Impairment of gastrointestinal function

• Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol.

• History of severe allergic reaction to any of the study intervention components

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.