NCT07124793

A Study of IBI363 Combination Therapy in Participants With Advanced Solid Tumors

Phase II Study to Evaluate the Efficacy and Safety of IBI363 in Combination With IBI305 in Participants With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

CIBI363A203, a Phase 2 study to evaluate the safety, tolerability and preliminary efficacy of IBI363 combined with IBI305 (a bevacizumab biosimilar) in participants with advanced malignancies conducted in China. Primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include DoR, DCR, TTR, PFS, per RECIST v1.1, and OS; the incidence and severity of AEs, irAEs, SAEs, AESIs and their relationship to the investigational drug, and changes in vital signs, physical examination, and laboratory values before and after study treatment; PK, and immunogenicity of IBI363. The cohorts include: IBI363 and IBI305 combination therapy in participants with advanced EGFRmut NSCLC progressed after EGFR TKI and Platinum-based chemotherapy, and advanced platinum-resistant ovarian cancer (PROC). The anticipated enrollment for this study is approximately 60 participants with each cohort 30 participants, and actual enrollment may change with future amendments as cohorts are opened and closed based on evolving data.

Conditions

• EGFR Mutant NSCLC and Platinum Resistant Ovarian Cancer

Interventions

Type	Name	Description
DRUG	IBI363+IBI305	Each treatment cycle lasts for 21 days (the first treatment cycle is 28 days). Subjects will receive IBI363 Q3W in combination with bevacizumab Q3W until 2 years of treatment, PD, intolerable toxicity, start of new anti-tumor treatment, withdrawal of informed consent, death, or study termination (whichever occurs first).

Timeline

• Start date: 2025-08-31
• Primary completion: 2026-09-30
• Completion: 2028-09-30
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: China