Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors
NCT ID: NCT03634982
Last Updated: 2022-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
133 participants
INTERVENTIONAL
2018-09-28
2023-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RMC-4630
RMC-4630 for oral administration
RMC-4630
RMC-4630 for oral administration
Interventions
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RMC-4630
RMC-4630 for oral administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Revolution Medicines, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Revolution Medicines, Inc.
Role: STUDY_DIRECTOR
Revolution Medicines, Inc.
Locations
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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
Countries
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Other Identifiers
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RMC-4630-01
Identifier Type: -
Identifier Source: org_study_id
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