Status:
TERMINATED
Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Revolution Medicines, Inc.
Mirati Therapeutics Inc.
Conditions:
Metastatic Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Primary Objectives: * Part 1 * To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors. * To define the MTD and RP2D for ...
Detailed Description
This open label Phase 1 multicenter study was designed to evaluate the safety and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SAR442720 in combination with pembrolizumab in par...
Eligibility Criteria
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 was 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 was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04418661
Start Date
June 9 2020
End Date
April 4 2024
Last Update
May 29 2025
Active Locations (20)
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1
University of California Irvine Medical Center- Site Number : 8400002
Orange, California, United States, 92868
2
The University of Texas MD Anderson Cancer Center- Site Number : 8400001
Houston, Texas, United States, 77030
3
Investigational Site Number : 0320003
Rosario, Santa Fe Province, Argentina, 2000
4
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1019