NCT06281678

A Study of IBI363 in Subjects with Advanced Solid Malignancies

A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.

Conditions

• Melanoma
• Non-small Cell Lung Cancer
• Colorectal Cancer
• Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	IBI363	IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. Subjects will receive study medication until disease progression, toxicity intolerance, withdrawal of consent, the duration of treatment reaches 24 months, or any other reason that requires discontinuation of the study treatment, whichever occurs first.

Timeline

• Start date: 2024-04-08
• Primary completion: 2026-03-01
• Completion: 2026-12-31
• First posted: 2024-02-28
• Last updated: 2024-12-19

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study