NCT05636215

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

A Phase 1/2, Multicenter, Open-label Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 368 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Unresectable or Metastatic Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	IBI354	Recombinant Anti-HER2 monoclonal Antibody-Camptothecin derivative conjugate for injection

Timeline

• Start date: 2023-04-04
• Primary completion: 2025-04-30
• Completion: 2025-10-31
• First posted: 2022-12-05
• Last updated: 2025-03-20

Locations

6 sites across 2 countries: Australia, China