A Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Status:
Not yet recruiting
Trial end date:
2026-05-01
Target enrollment:
Participant gender:
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.