Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

Condition(s) studied

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

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)