NCT06349408

IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

A Phase 1 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.

Conditions

• Locally Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	IBI3001	The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study. IBI3001 is proposed to be administered by intravenous infusion (IV)

Timeline

• Start date: 2025-01-10
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-04-05
• Last updated: 2025-01-27

Locations

5 sites across 2 countries: Australia, China