Phase 1 Study of ASP5834 Alone or with Panitumumab in Adults With Advanced Solid Tumors Having KRAS Mutations or Amplifications

What this Trial Is About

Researchers are studying ASP5834, a new drug given for the first time to adults with advanced or metastatic solid tumors that have specific mutations or amplifications in the KRAS gene. The study aims to find a suitable dose of ASP5834 alone or combined with panitumumab, a treatment for colorectal cancer. It also evaluates the safety and tolerability of these treatments in people whose cancers have not responded to or cannot receive standard therapies. The study has two parts Dose Escalation and Dose Expansion. In Dose Escalation, small groups receive increasing doses of ASP5834 alone or with panitumumab the latter only for colorectal cancer. In Dose Expansion, groups receive the selected doses from the first part. Both drugs are given by intravenous infusion in cycles lasting 21 or 28 days. Treatment continues until side effects become intolerable, cancer worsens, other treatments start, or the participant chooses to stop. Participants will visit the clinic regularly, especially during the first two treatment cycles, for health checks, scans to monitor cancer, and tumor sample collection. After stopping treatment, follow-up visits will occur every few months to assess health and cancer status. The study is expected to last about one year per participant. Researchers will monitor side effects, laboratory tests, heart and eye function, and cancer response throughout the study.

A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors