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RECRUITING
NCT06770439
PHASE2

IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

Sponsor: Zhejiang University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2025-04-18

Completion Date

2028-01

Last Updated

2025-09-23

Healthy Volunteers

No

Interventions

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

Locations (2)

First Affiliated Hospital of Zhejiang University Schlool of Medicine

Hangzhou, Zhejiang, China

the First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China