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BRIEF TITLE: A Phase 1b/2, Open-Label, Multicenter Dose-Escalation and Dose-Expansion Study of the Combination of RMC-4630 and Cobimetinib in Adult Participants With Relapsed/Refractory Solid Tumors With Specific Genomic Aberrations

A Phase 1b/2, Open-Label, Multicenter Dose-Escalation and Dose-Expansion Study of the Combination of RMC-4630 and Cobimetinib in Adult Participants With Relapsed/Refractory Solid Tumors With Specific Genomic Aberrations

  • Org Study ID: RMC-4630-02
  • Secondary ID:
  • NCT ID: NCT03989115
  • NCT Alias:
  • Sponsor: Revolution Medicines, Inc. - Industry
  • Source: Revolution Medicines, Inc.

Brief 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).

Detailed Description

This open-label, phase 1b/2 dose-escalation and dose-expansion study is designed to evaluate
the safety and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of RMC-4630
in combination with cobimetinib in participants with relapsed/refractory solid tumors.

Overal Status Start Date Phase Study Type
Recruiting July 3, 2019 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of participants with adverse events (AEs)

Primary Outcome 1 - Time Frame: up to 3 years

Primary Outcome 2 - Measure: Number of participants with dose limiting toxicities (DLTs)

Primary Outcome 2 - Time Frame: 28 days


  • Solid Tumor


Inclusion Criteria:

- Age ≥18 years

- 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.

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

- Participants must have one of the following genotypic aberrations: KRAS mutations and
amplifications, BRAF Class 3 mutations, or NF1 LOF mutations

- 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 .

Exclusion Criteria:

- Primary central nervous system (CNS) tumors.

- Known or suspected leptomeningeal or brain metastases or spinal cord compression.

- 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

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Revolution Medicines, Inc.

Role: Study Director

Affiliation: Revolution Medicines, Inc.

Overall Contact

Name: Revolution Medicines, Inc.

Phone: (650) 779-2300



Facility Status Contact
Honor Health Research Institute
Scottsdale, Arizona 85258
United States
Recruiting Joyce Schaffer
City of Hope
Duarte, California 91010
United States
Recruiting Marianna Koczywas, MD
UC Irvine - Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
Recruiting Sai-Hong Ignatius Ou, MD
UC Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Recruiting Corinne Turrell
UC San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94115
United States
Recruiting Melissa Lopez
University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Recruiting Kristen Califano
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United States
Recruiting Shawn Reese
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United States
Recruiting Jenn Hale
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting Christopher Graham
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting Misako Nagasaka
Levine Cancer Institute - Charlotte
Charlotte, North Carolina 28204
United States
Recruiting Heather Neagle
Ohio State University
Columbus, Ohio 43210
United States
Recruiting Carly Pilcher
University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Dena Suthers
Providence Cancer Institute, Franz Clinic
Portland, Oregon 97213
United States
Recruiting Christina Lopez
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Recruiting Martin Edelman, MD
Sarah Cannon Research Institute - Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United States
Recruiting Lauren Taylor
Dell Seton Medical Center at University of Texas
Austin, Texas 78712
United States
Recruiting Staci Eaton
Virginia Cancer Specialists (Fairfax) - USOR
Fairfax, Virginia 22031
United States
Recruiting Alexander Spira, MD
University of Wisconsin
Madison, Wisconsin 53792
United States
Recruiting Cancer Connect