Phase 12 Study of IBI130 for Adults With Unresectable or Advanced Solid Tumors

What this Trial Is About

Researchers are conducting a phase 12 multicenter, open-label clinical trial to study IBI130 in patients with unresectable, locally advanced, or metastatic solid tumors. The study aims to find the maximum tolerated dose and recommended phase 2 dose of IBI130, and then explore its efficacy, safety, and tolerability in these patients. The trial plans to enroll between 20 and 182 subjects in phase 1 and about 150 evaluable subjects in phase 2. Participants will receive IBI130 until unacceptable side effects occur, the disease progresses, they withdraw consent, or for a maximum of 24 months, whichever happens first. The study includes a dose escalation and expansion phase in phase 1 to identify appropriate dosing, followed by a phase 2 period to evaluate treatment responses. There is no placebo group, and all participants receive IBI130. During the study, researchers will monitor adverse events up to 30 days after the last dose. They will also assess objective response rate, duration of response, and overall survival for up to 3 years following the first dose. Participants will undergo evaluations to track treatment effects and safety throughout their involvement. The total length of participation varies based on individual treatment duration and follow-up assessments.

A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors