Study Of RMC-6236 In Patients With Advanced Solid Tumors Harboring Specific Mutations In RAS

Study Overview

Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.

This is a Phase 1/1b, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within investigated patient population groups. RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms (HRAS, NRAS, and KRAS).

Non-small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Pancreatic Ductal Adenocarcinoma (PDAC)
Advanced Solid Tumors

DRUG: RMC-6236

RMC-6236-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-05-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-11-12
First Submitted that Met QC Criteria 2022-05-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-11-14
First Posted (ACTUAL) 2022-05-18	Results First Posted N/A	Last Verified 2024-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Experimental: RMC-6236 Enrollment into dose exploration may be from any advanced solid tumor type with KRAS p.G12 mutations. Enrollment into dose expansion/optimization may be from groups consisting of patients with a single histotype/genotype (for example, KRAS G12-mutated NS	DRUG: RMC-6236 Oral Tablets

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Experimental: RMC-6236

Enrollment into dose exploration may be from any advanced solid tumor type with KRAS p.G12 mutations. Enrollment into dose expansion/optimization may be from groups consisting of patients with a single histotype/genotype (for example, KRAS G12-mutated NS

DRUG: RMC-6236

Oral Tablets

Primary Outcome Measures	Measure Description	Time Frame
Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs, including incidence and severity of findings in laboratory values and vital signs		up to 2.5 years
Number of Participants with Dose-Limiting Toxicity (DLT)		21 days

Secondary Outcome Measures	Measure Description	Time Frame
Maximum Observed Blood Concentration (Cmax) of RMC-6236		up to 15 weeks
Time to Reach Maximum Blood Concentration (Tmax) of RMC-6236		up to 15 weeks
Area Under Blood Concentration Time Curve (AUC) of RMC-6236		up to 15 weeks
Elimination Half-Life of RMC-6236 (t1/2)		up to 15 weeks
Ratio of accumulation of RMC-6236 from a single dose to steady state with repeated dosing		up to 15 weeks
Overall Response Rate (ORR)	Overall response rate per RECIST v1.1	up to 2.5 years
Duration of Response (DOR)	Duration of response per RECIST v1.1	up to 2.5 years
Disease Control Rate (DCR)	Disease control rate per RECIST v1.1	up to 2.5 years
Time to Response (TTR)	Time to response per RECIST v1.1	up to 2.5 years
Progression-Free Survival (PFS)	Progression-free survival per RECIST v1.1	up to 2.5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Revolution Medicines, Inc.

Phone Number: 1-844-273-8633

Email: medinfo@revmed.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization/expansion) identified through deoxyribonucleic acid (DNA) sequencing. PDAC with wild-type RAS (expansion).
Received prior standard therapy appropriate for tumor type and stage
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function

Primary central nervous system (CNS) tumors
Active, untreated brain metastases
Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
History of any other 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 prior/concomitant therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Revolution Medicines, Inc., Revolution Medicines, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record