drugset / Trial / NCT05636215

A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors

NCT05636215

Phase 1/2 Recruiting 368 enrolled Innovent Biologics (Suzhou) Co. Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI354 (study drug), and to explore and confirm the efficacy, safety and tolerability of IBI354 in subjects with locally advanced unresectable or metastatic solid tumors.

Timeline

Start
2023-04-04
Primary completion
2025-04-30
Completion
2025-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI354 Monoclonal antibody