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

Status unconfirmed · Phase 1

Conditions studied: Solid Tumors

In brief

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).

Key facts

Study ID

NCT03634982

Run by

Revolution Medicines, Inc.

People needed

133

Starts

2018-09-28

Expected to finish

2023-05-31

Last updated by the study team

2022-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Honor Health Research Institute — Scottsdale, Arizona, United States
• City of Hope — Duarte, California, United States
• UC Irvine - Chao Family Comprehensive Cancer Center — Orange, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• UC San Francisco - Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Sarah Cannon Research Institute - Florida Cancer Specialists — Sarasota, Florida, United States
• Moffit Cancer Center — Tampa, Florida, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Oklahoma - Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Sarah Cannon Research Institute - Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• University of Texas at Austin - Dell Medical School — Austin, Texas, United States

Full record on ClinicalTrials.gov

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