Suspended

A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants With Relapsed/Refractory Solid Tumors

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What is being tested

RMC-4630

Drug
Who is being recruted

Congenital Abnormalities+62

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2018
See protocol details

Summary

Principal SponsorRevolution Medicines, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 28, 2018

Actual date on which the first participant was enrolled.

This is an open-label, multicenter, Phase 1 study of oral RMC-4630 monotherapy in participants with advanced relapsed or refractory solid tumors. The study will include 2 components: 1) a Dose-Escalation Component for participants with relapsed or refractory solid tumors and 2) a Dose-Expansion Component for participants with relapsed or refractory solid tumors harboring certain specific mutations/rearrangements that result in hyperactivation of the RAS-MAPK pathway. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

Official TitleA Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants With Relapsed/Refractory Solid Tumors
NCT03634982
Principal SponsorRevolution Medicines, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

133 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesUrogenital DiseasesGenital DiseasesAdnexal DiseasesUrinary Bladder DiseasesUrinary Bladder NeoplasmsBronchial DiseasesBronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCardiovascular DiseasesUterine Cervical DiseasesUterine Cervical NeoplasmsConnective Tissue DiseasesDigestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsEsophageal DiseasesEsophageal NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersHead and Neck NeoplasmsHeart Defects, CongenitalHeart DiseasesLung DiseasesLung NeoplasmsMelanomaMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNoonan SyndromeOvarian DiseasesOvarian NeoplasmsRespiratory Tract DiseasesRespiratory Tract NeoplasmsSkin DiseasesSkin NeoplasmsThoracic NeoplasmsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsUterine DiseasesUterine NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNeoplasms, Squamous CellNevi and MelanomasNeuroendocrine TumorsCardiovascular AbnormalitiesCraniofacial AbnormalitiesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

7 inclusion criteria required to participate
Participant (male or female) ≥18 years of age
Participants who have advanced solid tumors that have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments including approved drugs for oncogenic drivers in their tumor type
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Participants in the Dose-Expansion Component must have one of the following genotypic aberrations: KRAS amplifications, KRASG12C (NSCLC), BRAF Class 3, or NF1 LOF (NSCLC and gynecological cancers) mutations
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9 exclusion criteria prevent from participating
Known or suspected leptomeningeal or brain metastases or spinal cord compression
Primary central nervous system (CNS) tumors
Clinically significant cardiac disease
Active, clinically significant interstitial lung disease or pneumonitis
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
RMC-4630 for oral administration

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Suspended

Honor Health Research Institute

Scottsdale, United StatesOpen Honor Health Research Institute in Google Maps
Suspended

City of Hope

Duarte, United States
Suspended

UC Irvine - Chao Family Comprehensive Cancer Center

Orange, United States
Suspended

UC Davis Comprehensive Cancer Center

Sacramento, United States
Suspended12 Study Centers