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Recruiting
NCT07349537
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
Conditions: Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC), PDAC, CRC, NSCLC, Pancreatic Cancer, Lung Cancer (NSCLC), Advanced Solid Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 574
Sponsor: Revolution Medicines, Inc.
Location: Yale Cancer Center New Haven Connecticut
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.
Eligibility Criteria
Inclusion Criteria:
* At least 18 years old and has provided informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.
* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.
* Measurable per RECIST v1.1
* Adequate organ function (bone marrow, liver, kidney, coagulation).
* Able to take oral medications.
Exclusion Criteria:
* Primary central nervous system (CNS) tumors
* Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and/or inhibitors).
* Any conditions that may affect the ability to take or absorb study drug.
* Major surgery within 28 days prior to receiving study drug(s).
* Patient is unable or unwilling to comply with protocol-required study visits or procedures.
Source: ClinicalTrials.gov (NCT07349537). StuddyBuddy aggregates publicly available trial information.