A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of 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, 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.
• 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 chemotherapy, targeted therapy, tumor immunotherapy, etc.).
• At least 1 measurable lesion (no previous radiotherapy) for solid tumors RECIST v1.1.(At baseline, computed tomography or magnetic resonance imaging showed the long diameter of 10 mm (except for lymph nodes, the short axis of the lymph node must be 15 mm), the diameter of the target lesion is 2 times the imaging layer thickness and the lesion is suitable for repeated accurate measurement. If a lesion located in the previously irradiated area clearly demonstrates a progression meeting the RECIST V1.1 criteria, the lesion acts as a measurable lesion).
• Age was 18 years, and gender was unlimited.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) was 0 or 1.
• The expected survival period was estimated at 12 weeks.
• Sufficient bone marrow and organ function.
• Female subjects of childbearing age or male partners of childbearing age should take effective contraception throughout the treatment period and within 6 months after the treatment period.
• Pathological tissue testing was confirmed as CLDN18.2 positive.