IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

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, patien

Trial Details

NCT ID
NCT06770439
Phase
PHASE2
Sponsor
Zhejiang University
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • IBI343
  • Gemcitabine+Albumin-bound paclitaxel
Locations (sample)
  • Hangzhou, Zhejiang, China|30.29365,120.16142
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

  • Signed written informed consent, willing and able to comply with the protocol specified visits and related procedures.
  • Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic pancreatic adenocarcinoma.
  • Subjects must not be eligible for radical treatment such as radical radiotherapy and / or surgery; time to disease recurrence / metastasis\> 6 mont…
  • At least 1 measurable lesion (no previous radiotherapy) for solid tumors RECIST v1.1.(At baseline, computed tomography or magnetic resonance imagin…

For full eligibility, visit ClinicalTrials.gov.

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