IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

This study is a phase II study to evaluate the safety, tolerability and efficacy of IBI343 combined with chemotherapy in patients with advanced pancreatic cancer, including Part1 (safe lead-in phase) and Part2 (extension phase). In part1, patients with CLDN18.2-positive advanced pancreatic adenocarcinoma who had or had not previously received systemic therapy were treated with chemotherapy in IBI343 with AG regimen (albumin paclitaxel with gemcitabine). In part2, 40 patients with CLDN18.2-positive advanced PDAC will be enrolled, 1:1 randomized to Arm A and Arm B, respectively. In Arm A, patients will receive IBI343 TBD + gemcitabine TBD + albumin-bound paclitaxel TBD; and in Arm B, patients will receive gemcitabine 1000mg / m2 d1, d8 Q3W + albumin-bound paclitaxel 125mg / m2d1, d8 Q3W treatment.

NCT Number	NCT06770439
Lead Sponsor	Zhejiang University
Conditions	Advanced Pancreatic Cancers
Enrollment	64 participants
Start Date	2025-04-18
Primary Completion	2027-01 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-23