RecruitingPhase 2NCT06770439

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


Sponsor

Zhejiang University

Enrollment

64 participants

Start Date

Apr 18, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of IBI343 (a new antibody drug) with chemotherapy as a treatment for advanced pancreatic cancer that cannot be surgically removed or has spread to other parts of the body. **You may be eligible if...** - You have confirmed advanced, unresectable, or metastatic pancreatic adenocarcinoma (a common type of pancreatic cancer) - You are not eligible for surgery or curative radiotherapy - You have measurable disease on imaging - Your general health and organ function are adequate **You may NOT be eligible if...** - You are currently enrolled in another interventional clinical trial - You received other anti-tumor therapy recently (within 2 weeks or 5 half-lives) - You have received strong CYP3A4 inhibitor medications within 2 weeks - You have severe or uncontrolled infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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

DRUGIBI343

IBI343 is a recombinant anti-tight junction protein 18.2 monoclonal antibody - ecotecan conjugate

DRUGGemcitabine+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

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NCT06770439


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