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).
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 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
- 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 .
- 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
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Revolution Medicines, Inc.
Role: Study Director
Affiliation: Revolution Medicines, Inc.
Name: Revolution Medicines, Inc.
Phone: (650) 779-2300
|Honor Health Research Institute
Scottsdale, Arizona 85258
|City of Hope
Duarte, California 91010
Marianna Koczywas, MD
|UC Irvine - Chao Family Comprehensive Cancer Center
Orange, California 92868
Sai-Hong Ignatius Ou, MD
|UC San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94115
|Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
|Karmanos Cancer Institute
Detroit, Michigan 48201
|University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
|Sarah Cannon Research Institute - Tennessee Oncology, PLLC
Nashville, Tennessee 37203
|Dell Seton Medical Center at University of Texas
Austin, Texas 78712