Phase 1 Study of ERAS-4001 Given Alone or with Other Treatments in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are studying ERAS-4001, a drug being evaluated for safety and tolerability in patients with advanced or metastatic solid tumors that have specific KRAS mutations. This first-in-human, Phase 11b, open-label, multicenter study aims to find the best doses of ERAS-4001 alone and combined with other cancer therapies. The study is sponsored by Erasca, Inc. and focuses on patients who have limited or no effective standard treatment options available. The study involves two treatment groups one receiving escalating oral doses of ERAS-4001 alone, and the other receiving ERAS-4001 orally combined with another investigational agent such as Keytruda or Vectibix, administered intravenously. The study begins with dose optimization for ERAS-4001 monotherapy and then moves to dose optimization of ERAS-4001 in combination with other therapies. Treatments are given under close monitoring to determine appropriate dosing and evaluate drug behavior in the body. Participants will be monitored for dose-limiting toxicities, maximum tolerated dose, and adverse events from the first day up to 21 days, with additional pharmacokinetic measurements like plasma concentration and half-life assessed up to 65 days. Researchers will also observe objective response rate, duration, and time to response over a period of up to 24 months. Participants must attend protocol-required visits and assessments to track safety and drug effects during the study and follow-up periods.

A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.