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
Zhejiang University
64 participants
Apr 18, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
IBI343 is a recombinant anti-tight junction protein 18.2 monoclonal antibody - ecotecan conjugate
Gemcitabine+ Albumin-bound paclitaxel is one of the recommended first line regime for advanced pancreatic cancer
Locations(2)
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NCT06770439