Ovarian Cancer Clinical Trial

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

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); 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.

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Full 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; and of RMC-4630 in combination with osimertinib in adult participants with EGFR mutation-positive locally advanced or metastatic NSCLC.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

113

Study ID:

NCT03989115

Recruitment Status:

Completed

Sponsor:

Revolution Medicines, Inc.

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There are 24 Locations for this study

See Locations Near You

Honor Health Research Institute
Scottsdale Arizona, 85258, United States
City of Hope
Duarte California, 91010, United States
UC Irvine - Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
UC San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Northwestern University
Chicago Illinois, 60611, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21287, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States
Ohio State University
Columbus Ohio, 43210, United States
University of Oklahoma - Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Providence Cancer Institute, Franz Clinic
Portland Oregon, 97213, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Sarah Cannon Research Institute - Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Dell Seton Medical Center at University of Texas
Austin Texas, 78712, United States
Virginia Cancer Specialists (Fairfax) - USOR
Fairfax Virginia, 22031, United States
University of Wisconsin
Madison Wisconsin, 53792, United States
Severance Hospital Yonsei University Health System
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Seoul National University Hospital
Seoul , 11074, Korea, Republic of
Samsung Medical Center - PPDS
Seoul , 135-7, Korea, Republic of

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

113

Study ID:

NCT03989115

Recruitment Status:

Completed

Sponsor:


Revolution Medicines, Inc.

How clear is this clinincal trial information?

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