Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC

Study summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) proﬁles of RMC-4630 and cobimetinib in adult participants with relapsed/refractory solid tumors with specific genomic aberrations and to identify the recommended Phase 2 dose (RP2D); and to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) proﬁles of RMC-4630 and osimertinib in adult participants with EGFR mutation-positive locally advanced or metastatic NSCLC.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRMC-4630 and Cobimetinib

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 26, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?24 U.S. locations

Locations may change over time.

Who runs it?Revolution Medicines, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Revolution Medicines, Inc.
Interventions being studied: Drug: RMC-4630; Drug: Cobimetinib; Drug: Drug: Osimertinib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→Metastatic or stage IV→Recurrent or relapsed→Resistant or refractory→

Biomarkers

EGFR→

Treatment approach

Targeted therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Age ≥18 years
For RMC-4630 + Cobimetinib only - Participants who have advanced solid tumors that have failed, are intolerant to, or are considered ineligible for standard of care anti-cancer treatments including approved drugs for oncogenic drivers in their tumor type.
For RMC-4630 + Osimertinib only - Locally advanced or metastatic EGFR mutant NSCLC not amenable to curative surgery or radiotherapy
For RMC-4630 + Cobimetinib only - Participants must have one of the following genotypic aberrations: KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations
For RMC-4630 + Osimertinib only - Evidence of radiological documentation of progression with osimertinib monotherapy or an osimertinib containing regimen. Participants should not be considered a current candidate for 1st generation EGFR TKI's by the investigator.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Adequate hematological, hepatic, and renal function
Capable of giving signed informed consent form (ICF). Willing and able to compile with study requirements and restrictions
Life expectancy \>12 weeks
Female of childbearing potential and males with partners of childbearing potential must comply with effective contraception criteria .

Reasons someone may not be able to joinExclusion criteria

Primary central nervous system (CNS) tumors.
Known or suspected leptomeningeal or brain metastases or spinal cord compression.
For RMC-4630 + osimertinib arm only - Known or suspected Small cell, squamous, or pleomorphic lung transformations
Clinically significant cardiac disease
Active, clinically signiﬁcant interstitial lung disease or pneumonitis
History or current evidence of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or predisposing factors to RPED or RVO
Known HIV infection or active/chronic hepatitis B or C infection.
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
Females who are pregnant or breastfeeding

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Honor Health Research InstituteScottsdale, Arizona
City of HopeDuarte, California
UC Irvine - Chao Family Comprehensive Cancer CenterOrange, California
UC Davis Comprehensive Cancer CenterSacramento, California
UC San Francisco - Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
University of Colorado Cancer CenterAurora, Colorado
Moffitt Cancer CenterTampa, Florida
Winship Cancer Institute, Emory UniversityAtlanta, Georgia
Northwestern UniversityChicago, Illinois
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
Dana Farber Cancer InstituteBoston, Massachusetts
Karmanos Cancer InstituteDetroit, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 26, 2023. Always confirm current availability with the study team.

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