Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
Eligible patients will receive oral SAR442720 (also known as RMC-4630) with intravenous (IV) pembrolizumab once every 3 weeks (Q3W). The dose of SAR442720 will be escalated or de-escalated depending on the emerging safety data of the combination.
Conditions
This trial is treating people with solid cancers
Eligibility
Inclusion
- 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.
- Participants must have following molecular aberration (Part 3A and 3B): - KRAS G12C mutation.
- 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
- Predicted life expectancy <3 months.
- Primary central nervous system (CNS) tumors.
- Symptomatic or impending cord compression. Stable CNS disease is allowed.
- 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, viral vaccine that do not contain live virus within 7 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- 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.
Inclusion
- You are able to swallow medication by mouth.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Sanofi Aventis
Scientific Title
A Phase 1, Open-label, Multicenter, Safety Study of SAR442720 in Combination With Pembrolizumab in Patients With Advanced Malignancies
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