A Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Summary

This is an open-label, multicenter, dose escalation and expansion phase I /II study of IBI3004 in subjects with unresectable, locally advanced or metastatic solid tumors. It includes a phase 1 dose escalation and expansion section to identify Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of IBI3004. Accelerated titration and the Bayesian Optimal Interval (BOIN) design is used to find the MTD or RP2D, and the maximum sample size is 46. One or more dose levels will be selected for dose expansion, each dose group will be expanded to 30 subjects.

Timeline

Start

2024-08-19

Primary completion

2025-12-16

Completion

2025-12-16

Outcome

Outcome not reported

Stopped (Business): “The company's development strategy has been adjusted”

Drugs

Indications