Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC
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.
Checked against the public recordLast updated Jun 26, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Revolution Medicines, Inc.
- Interventions being studied
- Drug: RMC-4630; Drug: Cobimetinib; Drug: Drug: Osimertinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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 . Exclusion Criteria: * 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Honor Health Research InstituteScottsdale, Arizona
- City of HopeDuarte, California
- UC Irvine - Chao Family Comprehensive Cancer CenterOrange, California
- UC Davis Comprehensive Cancer CenterSacramento, California
- UC San Francisco - Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- University of Colorado Cancer CenterAurora, Colorado
- Moffitt Cancer CenterTampa, Florida
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia
- Northwestern UniversityChicago, Illinois
- Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
- Dana Farber Cancer InstituteBoston, Massachusetts
- Karmanos Cancer InstituteDetroit, Michigan
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 26, 2023. Always confirm current availability with the study team.