NCT06198426

A Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

A Phase 1/2, Multicenter, Open-label Study of IBI3004 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	IBI3004	IBI3004 will be administered. The Dose Limiting Toxicity (DLT) will be observed in the first treatment cycle. After completion of the DLT observation period, subjects will continue to receive IBI3004 until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, end of the study, or for a maximum of 24 months, whichever occurs first.

Timeline

• Start date: 2024-08-19
• Primary completion: 2025-12-16
• Completion: 2025-12-16
• First posted: 2024-01-10
• Last updated: 2025-12-30

Locations

5 sites across 2 countries: Australia, China