Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies

Stopped early · Phase 1/Phase 2

Conditions studied: Metastatic Neoplasm

In brief

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 the combination of SAR442720 and pembrolizumab in participants with solid tumors. * Part 2 * To determine the anti-tumor activity of SAR442720 in combination with pembrolizumab. * Part 3A * To define the MTD and RP2D for the combination of SAR442720 and adagrasib in participants with KRAS G12C NSCLC * To characterize the safety and tolerability of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC * Part 3B * To determine the anti-tumor activity of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC * Part 4 * To evaluate the impact of food on the PK of SAR442720 when dosed with pembrolizumab. * To evaluate the impact of the formulations (formulation 1 and formulation 2) on the PK of SAR442720 when dosed with pembrolizumab. Secondary Objectives: * Part 1 * To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. * To estimate the anti-tumor effects of SAR442720 with pembrolizumab. * Part 2 * To assess the safety profile of SAR442720 combined with pembrolizumab. * To assess other indicators of anti-tumor activity. * To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. * Part 3A * To characterize the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. * To estimate the anti-tumor effects of SAR442720 with adagrasib * Part 3B * To assess the safety profile of SAR442720 with adagrasib in participants with KRAS G12C NSCLC. * To assess other indicators of anti-tumor activity. * To assess the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. * Part 4 * To assess the safety and tolerability of SAR442720 formulations with pembrolizumab * To estimate the anti-tumor effects of SAR442720 with pembrolizumab.

Key facts

Study ID

NCT04418661

Run by

Sanofi

People needed

65

Starts

2020-06-09

Expected to finish

2024-04-04

Last updated by the study team

2025-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California Irvine Medical Center- Site Number : 8400002 — Orange, California, United States
• The University of Texas MD Anderson Cancer Center- Site Number : 8400001 — Houston, Texas, United States
• Investigational Site Number : 0320003 — Rosario, Santa Fe Province, Argentina
• Investigational Site Number : 0320001 — Buenos Aires, Argentina
• Investigational Site Number : 0320004 — Buenos Aires, Argentina
• Investigational Site Number : 0320002 — Buenos Aires, Argentina
• Investigational Site Number : 0360002 — Sydney, New South Wales, Australia
• Investigational Site Number : 0360001 — Woolloongabba, Queensland, Australia
• Investigational Site Number : 0360003 — Melbourne, Victoria, Australia
• Investigational Site Number : 1520002 — Temuco, La Araucanía, Chile
• Investigational Site Number : 1520001 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520003 — Viña del Mar, Valparaiso, Chile
• Investigational Site Number : 4100002 — Seongnam-si, Gyeonggi-do, South Korea
• Investigational Site Number : 4100003 — Cheongju-si, North Chungcheong, South Korea
• Investigational Site Number : 4100001 — Seoul, Seoul-teukbyeolsi, South Korea
• Investigational Site Number : 7240001 — Madrid, Spain
• Investigational Site Number : 7240002 — Madrid, Spain
• Investigational Site Number : 7240003 — Valencia, Spain
• Investigational Site Number : 1580002 — Tainan, Taiwan
• Investigational Site Number : 1580001 — Taipei, Taiwan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.