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
| Condition(s) | Advanced Pancreatic Cancers |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 trea |
| Who can participate | Inclusion 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 months for subjects with previous (new) adjuvant / adjuvant / radiotherapy) chemotherapy / radical chemoradiotherapy. In part 1: locally advanced or recurrent / metastatic stage with or without systemic therapy (including chemotherapy, targeted therapy, tumor immunotherapy, etc.). In part 2: The locally advanced or recurrent / metastasis phase has not received any systemic therapy (including chem |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Zhejiang University |
| Locations | Hangzhou, Zhejiang, China; Hangzhou, Zhejiang, China |
| Start date | 2025-04-18 |
| NCT ID | NCT06770439 |
| Official listing | https://clinicaltrials.gov/study/NCT06770439 |