NCT07342725

Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an Ib/II phase clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a second-line treatment for unresectable locally advanced or metastatic pancreatic cancer. Approximately 39-48 patients with unresectable locally advanced or metastatic pancreatic cancer, who have progressed on or are intolerant to first-line chemotherapy (albumin-bound paclitaxel + gemcitabine, AG regimen), will be enrolled. Treatment involves IBI363 combined with chemotherapy and continues until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons for discontinuation.

Conditions

• Pancreatic Cancer Metastatic

Interventions

Type	Name	Description
DRUG	IBI363 + chemotherapy	IBI363+chemotherapy

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-01-15
• Last updated: 2026-01-15