Clinical trial · Interventional
Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies
A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of SAR442720 in Combination With Other Agents in Participants With Advanced Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's decision not related to any safety concern
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Neoplasm | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adagrasib | Drug | Adagrasib | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Vociprotafib | Drug | Vociprotafib | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Part 1- SAR442720 140 mg BIW + Pembrolizumab
- description
- Participants were administered SAR442720 140 milligram (mg) orally twice a week (BIW) on Days 1 and 4 along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day cycles until disease progression, unacceptable adverse events (AEs), or the participant's or investigator's decision to stop the treatment.
- interventionNames
- Drug: Vociprotafib
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Part 1- SAR442720 200mg BIW + Pembrolizumab
- description
- Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
- interventionNames
- Drug: Vociprotafib
- Drug: Pembrolizumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. * 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 Criteria: * 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.
References
Publications (0)
Data not yet available