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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
Not yet recruiting Study Coordinator

City of Hope
Duarte, California 91010
United States
Not yet recruiting Study Coordinator

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
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