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CompletedLast updated: 11 April 2024

This phase I trial is designed to evaluate the safety and maximum tolerated dose (MTD) of a new oral drug, given in combination with a type of immunotherapy in patients with solid cancersA Phase 1, Open-label, Multicenter, Safety Study of SAR442720 in Combination With Pembrolizumab in Patients With Advanced Malignancies

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 patients with solid cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

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Completed hospitals

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