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

Completed · Phase 1/Phase 2

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID: NCT03989115
Run by: Revolution Medicines, Inc.
People needed: 113
Starts: 2019-07-02
Expected to finish: 2022-02-08
Last updated by the study team: 2023-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 .

You may not qualify if…

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

Where it is running

Honor Health Research Institute — Scottsdale, Arizona, United States
City of Hope — Duarte, California, United States
UC Irvine - Chao Family Comprehensive Cancer Center — Orange, California, United States
UC Davis Comprehensive Cancer Center — Sacramento, California, United States
UC San Francisco - Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
University of Colorado Cancer Center — Aurora, Colorado, United States
Moffitt Cancer Center — Tampa, Florida, United States
Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
Northwestern University — Chicago, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Karmanos Cancer Institute — Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Ohio State University — Columbus, Ohio, United States
University of Oklahoma - Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
Providence Cancer Institute, Franz Clinic — Portland, Oregon, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute - Tennessee Oncology, PLLC — Nashville, Tennessee, United States
Dell Seton Medical Center at University of Texas — Austin, Texas, United States
Virginia Cancer Specialists (Fairfax) - USOR — Fairfax, Virginia, United States
University of Wisconsin — Madison, Wisconsin, United States
Severance Hospital Yonsei University Health System — Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital — Seoul, South Korea
Samsung Medical Center - PPDS — Seoul, South Korea

Full record on ClinicalTrials.gov

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