Back to Clinical Trials

Brief Title: Dose-Escalation/Expansion of RMC-4630 and Cobimetinib in Relapsed/Refractory Solid Tumors and RMC-4630 and Osimertinib in EGFR Positive Locally Advanced/Metastatic NSCLC

A Phase 1b/2, Open-Label, Multicenter Dose-Escalation and Dose-Expansion Study of the Combination of RMC-4630 and Cobimetinib in Adult Participants With Relapsed/Refractory Solid Tumors and a Phase 1b Study of RMC-4630 With Osimertinib in Participants With EGFR Mutation Positive, Locally Advanced or Metastatic NSCLC

INTRODUCTION

  • Org Study ID: RMC-4630-02
  • Secondary ID: N/A
  • NTC ID: NCT03989115
  • Sponsor: Revolution Medicines, Inc.

BRIEF 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.

DETAILED 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.


  • Overall Status
    Recruiting
  • Start Date
    July 2, 2019
  • Phase
    Phase 1/Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with adverse events (AEs)

Primary Outcome 1 - Timeframe: up to 3 years

Primary Outcome 2 - Measure: Number of participants with dose limiting toxicities (DLTs)

Primary Outcome 2 - Timeframe: 28 days

CONDITION

  • Solid Tumor

ELIGIBILITY


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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Revolution Medicines, Inc.

Role: Study Director

Affiliation: Revolution Medicines, Inc.

Overall Contact

Name: Revolution Medicines, Inc.

Phone: (650) 779-2300

Email: CT-Inquiries@RevMed.com

LOCATION

Facility Status Contact
Facility: Honor Health Research Institute
Scottsdale, Arizona 85258
United States
Status: Recruiting Contact:
Joyce Schaffer
480-323-1791
clinicaltrials@honorhealth.com
Facility: City of Hope
Duarte, California 91010
United States
Status: Recruiting Contact:
Marianna Koczywas, MD
626-256-4673
mkoczywas@coh.org
Facility: UC Irvine - Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
Status: Recruiting Contact:
Sai-Hong Ignatius Ou, MD
714-456-8014
ignatius.ou@uci.edu
Facility: UC Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Status: Recruiting Contact:
Corinne Turrell

ceturrell@ucdavis.edu
Facility: UC San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94115
United States
Status: Recruiting Contact:
Delaire Fattah
415-514-9286
Delaire.Fattah@ucsf.edu
Facility: University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Status: Recruiting Contact:
Kristen Califano
720-848-0592
Kristen.Califano@cuanschutz.edu
Facility: Moffitt Cancer Center
Tampa, Florida 33612
United States
Status: Recruiting Contact:
Ashley Derigo
813-745-5995
Ashley.derigo@moffitt.org
Facility: Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact:
Shawn Reese
404-778-8040
shawn.reese@emory.edu
Facility: Northwestern University
Chicago, Illinois 60611
United States
Status: Recruiting Contact:
Study Coordinator
312-695-1301
cancertrials@northwestern.edu
Facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United States
Status: Recruiting Contact:
Jenn Hale

jennhale@jhu.edu
Facility: Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact:
Christopher Graham

Christopher_graham@dfci.harvard.edu
Facility: Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Status: Recruiting Contact:
Misako Nagasaka
313-576-8753
nagasakm@karmanos.org
Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10021
United States
Status: Recruiting Contact:
Kathryn Arbour, MD
646-608-3792
arbourk@mskcc.org
Facility: Levine Cancer Institute - Charlotte
Charlotte, North Carolina 28204
United States
Status: Recruiting Contact:
Heather Neagle
980-442-2303
Heather.Neagle@atriumhealth.org
Facility: Ohio State University
Columbus, Ohio 43210
United States
Status: Recruiting Contact:
Carly Pilcher

Carly.Pilcher@osumc.edu
Facility: University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact:
Dena Suthers
405-271-8778
dena-suthers@ouhsc.edu
Facility: Providence Cancer Institute, Franz Clinic
Portland, Oregon 97213
United States
Status: Recruiting Contact:
Christina Lopez

CanRsrchStudies@providence.org
Facility: Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Status: Recruiting Contact:
Martin Edelman, MD
215-728-5682
martin.edelman@fccc.edu
Facility: Sarah Cannon Research Institute - Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United States
Status: Recruiting Contact:
Elizabeth Miller
615-329-7252
elizabeth.miller@sarahcannon.com
Facility: Dell Seton Medical Center at University of Texas
Austin, Texas 78712
United States
Status: Recruiting Contact:
Staci Eaton
512-495-5500
staci.eaton@austin.utexas.edu
Facility: Virginia Cancer Specialists (Fairfax) - USOR
Fairfax, Virginia 22031
United States
Status: Recruiting Contact:
Alexander Spira, MD

alexander.spira@usoncology.com
Facility: University of Wisconsin
Madison, Wisconsin 53792
United States
Status: Recruiting Contact:
Cancer Connect
800-622-8922
Facility: Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic of
Status: Recruiting Contact:
Hyun Cheol Chung, MD, PhD
+82 2 2228 8132
unchung8@yuhs.ac
Facility: Seoul National University Hospital
Seoul, 110744
Korea, Republic of
Status: Recruiting Contact:
Do-Youn Oh, MD
+82 2 2072 0701
ohdoyoun@snu.ac.kr
Facility: Samsung Medical Center - PPDS
Seoul, 135-710
Korea, Republic of
Status: Recruiting Contact:
Jeeyun Lee, MD, PhD
+82 2 3410 1779
jyun.lee@samsung.com