Phase 1 Evaluation of ASP3082 in Adults with Advanced or Metastatic Solid Tumors Having KRAS G12D Mutation

What this Trial Is About

Researchers are evaluating ASP3082, a drug given by intravenous infusion, in adults with advanced or metastatic solid tumors that have a specific mutation called KRAS G12D. This open-label Phase 1 study aims to check the safety and tolerability of ASP3082 alone or combined with other treatments like cetuximab, FOLFIRINOX, Nab-Paclitaxel plus gemcitabine, docetaxel, pembrolizumab, platinum-based chemotherapy, and NALIRIFOX. Participants have tumors that have not responded to or are ineligible for standard therapies. The study consists of two parts. In Part 1, small groups of participants receive escalating doses of ASP3082 alone or with cetuximab to find suitable doses. In Part 2, participants receive ASP3082 alone or combined with other study treatments at doses selected from Part 1. Treatments are given by infusion in cycles of 21 or 28 days. Participants continue treatment until intolerable side effects, disease progression, start of other cancer therapy, or withdrawal. Throughout the study, participants undergo regular monitoring for side effects, physical exams, lab tests, ECGs, and assessments of tumor response using standard criteria. Safety is tracked up to 48 months. Researchers collect tumor samples before and during treatment to study changes in the KRAS mutation. Participants overall health and performance status are also evaluated during the study, which may last several years depending on individual outcomes and treatment responses.

A Study of ASP3082 in Adults With Advanced Solid Tumors