NCT05458219

A First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

A Phase 1a/b, Multicenter, Open-label, First-in-human Study of IBI343 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 470 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ia/Ib, multicenter, open-label, first-in-human study to evaluate the safety, tolerability, PK, and efficacy of IBI343 in participants with locally advanced unresectable or metastatic solid tumors. It is planned to be carried out in different countries or regions such as China, Australia and US. There are three parts in phase Ia. Part 1 includes dose escalation and expansion phase and part 2 is designed for dose optimization for IBI343 monotherapy. Part 3 1L G/GEJ AC and 1L PDAC cohorts will include an initial safety lead-in stage to confirm the tolerability of IBI343 in combination with chemotherapy in 1L PDAC and G/GEJ AC, followed by a randomized dose-optimization stage designed to further characterize safety, pharmacokinetics, and preliminary efficacy to inform selection of the recommended Phase 3 dose. Part 3 metabolite profiling cohort is designed to explore the payload metabolites in an advanced PDAC population.

Conditions

• Locally Advanced Unresectable or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	IBI343	IBI343 will be administered intravenously (IV) on Day 1 of every 21-day cycle.
DRUG	FOLFIRINOX/mFOLFIRINOX	FOLFIRINOX/mFOLFIRINOX will be administered IV Q2W on Days 1-3 every 2 weeks (14 days).
DRUG	mFOLFOX	mFOLFOX will be administered IV Q2W on Days 1-3 every 2 weeks (14 days) in each cycle after IBI343
DRUG	IBI343	IBI343 will be administered IV Q2W on Day1 (14 days).

Timeline

• Start date: 2022-10-26
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2022-07-14
• Last updated: 2025-11-10

Locations

39 sites across 3 countries: United States, Australia, China

Regulatory

• FDA-regulated drug study