A study of RMC-6291 in combination with pembrolizumab in participants with solid tumors with certain mutations- Subprotocol A

Phase 1

Recruiting

• Conditions: ung Cancer; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-509571-16-00
• Lead Sponsor: Revolution Medicines Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-29
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

1. = 18 years of age and signed the Informed Consent Form (ICF) 2. Patients that have solid tumor with KRAS mutation. 3. Patients that have received prior cancer treatment. 4. Patients that have at least one tumor lesion (an area of abnormal tissue) that can be measured. 5. Patients that have adequate organ function (bone marrow, liver, kidney).

Exclusion Criteria

1. Participants that have primary brain and spinal cord tumor. 2. Participants thathave gastrointestinal problems that may affect absorption of RMC-6291. 3. Participants thathad any major surgery in the last 4 weeks. 4. Participants thathave any other medical condition that may interfere with the study drugs. 5. Participants that have previously taken targeted therapy for KRAS mutation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of RMC-6291 in<br>combination with pembrolizumab, with or without<br>chemotherapy, in patients with advanced KRAS G12C mutated solid tumors;Secondary Objective: To characterize the plasma PK profile of RMC-6291 in combination with pembrolizumab in patients with advanced KRASG12C-mutated solid tumors. To evaluate preliminary antitumor activities of RMC-6291 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced KRASG12Cmutated solid tumors, including NSCLC.;Primary end point(s): • Incidence of DLTs (Part 1 and Part 2 Cohort 2 safety lead-in only) •Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in laboratory test values, ECGs, and vital signs.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):• Concentrations of RMC-6291 in plasma over time and PK parameters as applicable. • ORR and DOR per RECIST v1.1