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BRIEF TITLE: A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants With 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


  • Org Study ID: RMC-4630-01
  • Secondary ID:
  • NCT ID: NCT03634982
  • 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 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.

Overal Status Start Date Phase Study Type
Recruiting September 28, 2018 Phase 1 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 Tumors

Eligibility

Criteria:
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: RTK mutations, amplifications or rearrangements, KRASG12, BRAF Class 3,
or NF1 LOF 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
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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
UC Irvine Medical Center - Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
Recruiting Sai-Hong Ignatius Ou, MD, PhD
877-824-3627
ucstudy@uci.edu
Sarah Cannon Research Institute - Florida Cancer Specialists
Sarasota, Florida 34232
United States
Recruiting Terri Peterson
941-377-9993
University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Study Coordinator
405-271-8778
Sarah Cannon Research Institute - Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United States
Recruiting ASKSARAH
877-691-7274
ASKSARAH@scresearch.net