Phase 2 Study of ABSK061 and ABSK043 to Treat Metastatic or Unresectable Solid Tumors with FGFR23 Alterations, With or Without Chemotherapy

What this Trial Is About

Researchers are evaluating the anti-tumor effects of two drugs, ABSK061 and ABSK043, in patients with metastatic or unresectable solid tumors that have specific FGFR2 or FGFR3 gene changes. This Phase 2 study focuses on tumors driven by FGFR alterations regardless of the tumor type. The study includes a screening phase, a treatment phase, and a follow-up period lasting until the participant dies, withdraws consent, is lost to follow-up, or the study ends, whichever comes first. Participants receive oral capsules of ABSK061 and ABSK043. Some patients with HER2-negative gastric or gastroesophageal junction cancer with FGFR2 changes will also receive chemotherapy called CAPOX along with the study drugs. Treatment continues until the disease worsens, unacceptable side effects occur, consent is withdrawn, or the investigator decides to stop treatment. The study follows patients for up to five years to monitor effects. During the study, participants undergo evaluations including tumor assessments by RECIST criteria, safety monitoring for dose-limiting toxicities, and pharmacokinetic tests measuring drug levels over time. Researchers will track outcomes such as overall response rate, progression-free survival, duration of response, disease control rate, and overall survival. Follow-up continues after treatment ends to collect long-term data and ensure patient safety throughout the study duration.

A Phase 2 Clinical Study of ABSK061 and ABSK043