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BRIEF TITLE: 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 With Specific Genomic Aberrations

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 With Specific Genomic Aberrations


  • Org Study ID: RMC-4630-02
  • Secondary ID:
  • NCT ID: NCT03989115
  • NCT Alias:
  • Sponsor: Revolution Medicines, Inc. - Industry
  • Source: 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).

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.

Overal Status Start Date Phase Study Type
Recruiting July 3, 2019 Phase 1/Phase 2 Interventional

Primary Outcomes:

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

Condition:

  • Solid Tumor

Eligibility

Criteria:
Inclusion Criteria:

- Age ≥18 years

- 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.

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

- Participants must have one of the following genotypic aberrations: KRAS mutations and
amplifications, BRAF Class 3 mutations, or NF1 LOF mutations

- 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.

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

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@RevolutionMedicines.com

Locations

Facility Status Contact
Honor Health Research Institute
Scottsdale, Arizona 85258
United States
Recruiting Joyce Schaffer
480-323-1791
clinicaltrials@honorhealth.com
City of Hope
Duarte, California 91010
United States
Recruiting Marianna Koczywas, MD
626-256-4673
mkoczywas@coh.org
UC Irvine - Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
Recruiting Sai-Hong Ignatius Ou, MD
714-456-8014
ignatius.ou@uci.edu
UC San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94115
United States
Recruiting Melissa Lopez
415-885-3728
Melissa.Lopez@ucsf.edu
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United States
Recruiting Shawn Reese
404-778-8040
shawn.reese@emory.edu
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting Misako Nagasaka
313-576-8753
nagasakm@karmanos.org
University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Dena Suthers
405-271-8778
dena-suthers@ouhsc.edu
Sarah Cannon Research Institute - Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United States
Recruiting Lauren Taylor
615-524-4037
lauren.taylor2@sarahcannon.com
Dell Seton Medical Center at University of Texas
Austin, Texas 78712
United States
Recruiting Staci Eaton
512-495-5500
staci.eaton@austin.utexas.edu