Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors
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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 1, 2022 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Revolution Medicines, Inc.
- Interventions being studied
- Drug: RMC-4630
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Honor Health Research InstituteScottsdale, Arizona
- City of HopeDuarte, California
- UC Irvine - Chao Family Comprehensive Cancer CenterOrange, California
- UC Davis Comprehensive Cancer CenterSacramento, California
- UC San Francisco - Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- University of Colorado Cancer CenterAurora, Colorado
- Sarah Cannon Research Institute - Florida Cancer SpecialistsSarasota, Florida
- Moffit Cancer CenterTampa, Florida
- Dana-Farber Cancer InstituteBoston, Massachusetts
- University of Oklahoma - Stephenson Cancer CenterOklahoma City, Oklahoma
- Sarah Cannon Research Institute - Tennessee Oncology, PLLCNashville, Tennessee
- University of Texas at Austin - Dell Medical SchoolAustin, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 1, 2022. Always confirm current availability with the study team.