Clinical Trials in the USA / NCT07349537
Recruiting
Phase 1
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
NCT07349537 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Non-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic AdenocarcinomaPancreatic Ductal Adenocarcinoma (PDAC)PDACCRCNSCLCPancreatic CancerLung Cancer (NSCLC)Advanced Solid Tumors
Investigational drug(s) / intervention(s)
RMC-5127: oral tablets
daraxonrasib: oral tablets
cetuximab: IV infusion
Study 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
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.
Primary outcome measure(s)
- Number of patients with adverse events (AEs) — Up to approximately 3 years
Number of patients with AEs as assessed by Common Terminology Criteria for Adverse Events CTCAE v5 - Changes in vital signs — Up to approximately 3 years
Number of patients with changes from baseline in vital signs - Changes in electrocardiogram (ECG) test values — Up to approximately 3 years
Number of patients with changes from baseline in ECG test values - Changes in clinical laboratory test values — Up to approximately 3 years
Number of patients with changes from baseline in clinical laboratory test values - Dose Limiting Toxicities — Up to 28 days
Number of patients with dose limiting toxicities
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Johns Hopkins | Baltimore | Maryland | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| START Midwest | Grand Rapids | Michigan | Recruiting |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | Recruiting |
| NEXT - Dallas | Dallas | Texas | Recruiting |
| NEXT | San Antonio | Texas | Recruiting |
| START - San Antonio | San Antonio | Texas | Recruiting |
| NEXT - Virginia | Fairfax | Virginia | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07349537 on ClinicalTrials.gov ↗ ← All trials in the USA