Evaluation of ERAS-0015 Alone and Combined with Other Cancer Treatments for Adults with Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating ERAS-0015, a drug being studied for safety and tolerability in adults with advanced or metastatic solid tumors that have certain RAS mutations. This first-in-human, Phase 11b, open-label, multicenter study aims to understand how ERAS-0015 works alone and in combination with other cancer treatments. The study begins with finding the right dose for ERAS-0015 alone, followed by dose optimization when combined with other cancer therapies. Participants will receive escalating oral doses of ERAS-0015 either by itself or alongside other investigational agents such as KEYTRUDA pembrolizumab or Vectibix panitumumab, both given by intravenous administration. The study design is sequential, starting with monotherapy dose optimization and then moving to combination dose optimization. Treatment dosing and schedules are carefully monitored throughout these periods. During the trial, participants will undergo assessments including monitoring for dose-limiting toxicities, adverse events, and pharmacokinetic measures like plasma concentration and half-life over several days. Responses to the treatment will be evaluated for up to 24 months from the first dose, including objective response rate and duration of response. Participants must comply with all visits and procedures, and the study includes safety monitoring to assess tolerability and dosing recommendations.

A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors