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Brief Title: Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors

A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants With Relapsed/Refractory Solid Tumors

INTRODUCTION

  • Org Study ID: RMC-4630-01
  • Secondary ID: N/A
  • NTC ID: NCT03634982
  • Sponsor: Revolution Medicines, Inc.

BRIEF SUMMARY


The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and
pharmacodynamic (PD) profiles of escalating doses of RMC-4630 monotherapy in adult
participants with relapsed/refractory solid tumors and to identify the recommended Phase 2
dose (RP2D).

DETAILED DESCRIPTION


This is an open-label, multicenter, Phase 1 study of oral RMC-4630 monotherapy in
participants with advanced relapsed or refractory solid tumors. The study will include 2
components: 1) a Dose-Escalation Component for participants with relapsed or refractory solid
tumors and 2) a Dose-Expansion Component for participants with relapsed or refractory solid
tumors harboring certain specific mutations/rearrangements that result in hyperactivation of
the RAS-MAPK pathway. Participants will be treated until disease progression per RECIST v1.1,
unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.


  • Overall Status
    Recruiting
  • Start Date
    September 28, 2018
  • Phase
    Phase 1
  • 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 Tumors

ELIGIBILITY


Inclusion Criteria:

- Participant (male or female) ≥18 years of age

- Participants who have advanced solid tumors that have failed, are intolerant to, or
are considered ineligible for standard of care anticancer treatments including
approved drugs for oncogenic drivers in their tumor type

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

- Participants in the Dose-Expansion Component must have one of the following genotypic
aberrations: KRAS amplifications, KRASG12C (NSCLC), BRAF Class 3, or NF1 LOF (NSCLC
and gynecological cancers) mutations

- Adequate hematologic, hepatic and renal function

- Participant able to understand and voluntarily sign the informed consent form (ICF)
and able to comply with the study visit schedule and other protocol requirements.

- Participants willing to agree to not father a child/become pregnant and comply with
effective contraception criteria

Exclusion Criteria:

- Known or suspected leptomeningeal or brain metastases or spinal cord compression

- Primary central nervous system (CNS) tumors

- 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

- 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
joschaffer@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, PhD
877-824-3627
ucstudy@uci.edu
Facility: UC Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Status: Recruiting Contact:
Steffany Lim, CCRP
916-734-0561
sllim@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:
Tara Wells
720-848-0755
TARA.WELLS@CUANSCHUTZ.EDU
Facility: Sarah Cannon Research Institute - Florida Cancer Specialists
Sarasota, Florida 34232
United States
Status: Recruiting Contact:
Terri Peterson
941-377-9993
tpeterson@flcancer.com
Facility: Moffit Cancer Center
Tampa, Florida 33612
United States
Status: Recruiting Contact:
Germaine M González-Vazquez
813-745-6636
germaine.gonzalezvazquez@moffitt.org
Facility: Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact:
Bryan Marion
617-632-3383
bryan_marion@dfci.harvard.edu
Facility: University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact:
Dena Suthers
405-271-8778
SCC-Clinical-Trials-Office@ouhsc.edu
Facility: Sarah Cannon Research Institute - Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United States
Status: Recruiting Contact:
Dee McComb
615-329-7478
researchreferrals@scresearch.net
Facility: University of Texas at Austin - Dell Medical School
Austin, Texas 78712
United States
Status: Recruiting Contact:
Anna Capasso
512-495-5516
anna.capasso@austin.utexas.edu