The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-4630 monotherapy in adult participants with relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).
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.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | September 28, 2018 | Phase 1 | 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
Criteria:
Inclusion Criteria:
- 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: RTK mutations, amplifications or rearrangements, KRASG12, BRAF Class 3,
or NF1 LOF mutations
- Adequate hematologic, hepatic and renal function
- Participant able to understand and voluntarily sign the informed consent form (ICF)
and able to comply with the study visit schedule and other protocol requirements.
- Participants willing to agree to not father a child/become pregnant and comply with
effective contraception criteria
Exclusion Criteria:
- 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
- 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
- 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
Name: Revolution Medicines, Inc.
Role: Study Director
Affiliation: Revolution Medicines, Inc.
Name: Revolution Medicines, Inc.
Phone: (650) 779-2300
Email: CT-Inquiries@RevolutionMedicines.com
Facility | Status | Contact |
---|---|---|
Honor Health Research Institute Scottsdale, Arizona 85258 United States |
Recruiting |
Joyce Schaffer 480-323-1791 |
City of Hope Duarte, California 91010 United States |
Recruiting | |
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center Orange, California 92868 United States |
Recruiting |
Sai-Hong Ignatius Ou, MD, PhD 877-824-3627 ucstudy@uci.edu |
University of Colorado Cancer Center Aurora, Colorado 80045 United States |
Recruiting |
Allison Owens 720-848-0667 Allison.Owens@ucdenver.edu |
Sarah Cannon Research Institute - Florida Cancer Specialists Sarasota, Florida 34232 United States |
Recruiting |
Terri Peterson 941-377-9993 |
Moffit Cancer Center Tampa, Florida 33612 United States |
Recruiting |
Germaine M González-Vazquez 813-745-6636 germaine.gonzalezvazquez@moffitt.org |
University of Oklahoma - Stephenson Cancer Center Oklahoma City, Oklahoma 73104 United States |
Recruiting |
Study Coordinator 405-271-8778 |
Sarah Cannon Research Institute - Tennessee Oncology, PLLC Nashville, Tennessee 37203 United States |
Recruiting |
ASKSARAH 877-691-7274 ASKSARAH@scresearch.net |