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IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

NCT06770439 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-09-23

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-18
Primary Completion
2027-01-31
Completion
2028-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06770439 on ClinicalTrials.gov