NCT06770439

IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Pancreatic Cancers

Interventions

Type	Name	Description
DRUG	IBI343	IBI343 is a recombinant anti-tight junction protein 18.2 monoclonal antibody - ecotecan conjugate
DRUG	Gemcitabine+Albumin-bound paclitaxel	Gemcitabine+ Albumin-bound paclitaxel is one of the recommended first line regime for advanced pancreatic cancer

Timeline

• Start date: 2025-04-18
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2025-01-13
• Last updated: 2025-09-23

Locations

2 sites across 1 country: China