Phase 1ab First-in-Human Study of IBI343 for Adults With Locally Advanced Unresectable or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating IBI343 in people with locally advanced unresectable or metastatic solid tumors in a Phase IaIb, multicenter, open-label, first-in-human study. The trial aims to assess the safety, tolerability, how the drug moves through the body, and its effectiveness. The study includes participants from China, Australia, and the US and involves various stages to find the best dose and combination therapies. IBI343 is given intravenously and the study is divided into multiple parts. Phase Ia includes dose escalation, dose expansion, and dose optimization for monotherapy, with doses adjusted to balance benefits and risks. Phase Ib includes combination therapy with chemotherapy drugs like FOLFIRINOX or mFOLFOX, given every two to three weeks, with randomized groups to determine the optimal dose and safety. Participants will have regular visits for treatment and monitoring, including physical exams, laboratory tests, and imaging to measure tumor response using RECIST criteria. Safety is closely followed through adverse event tracking up to two years, along with assessments of drug levels in the body and immune response. The study also evaluates how tumor markers relate to treatment response, with total participation lasting up to two years.

A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors