Actively Recruiting
IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer
Led by Zhejiang University · Updated on 2025-09-23
64
Participants Needed
2
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent and able to follow study visits and procedures
- Histologically confirmed unresectable locally advanced, recurrent, or metastatic pancreatic adenocarcinoma
- Not eligible for radical treatment like surgery or radical radiotherapy
- For Part 1: locally advanced or recurrent/metastatic stage with or without prior systemic therapy
- For Part 2: locally advanced or recurrent/metastatic stage with no prior systemic therapy
- At least one measurable lesion per RECIST v1.1 criteria
- Age 18 years or older
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
- Expected survival of at least 12 weeks
- Sufficient bone marrow and organ function
- Females of childbearing potential and male partners must use effective contraception during treatment and for 6 months after
- Tumor tissue confirmed CLDN18.2 positive
You will not qualify if you...
- Currently participating in another interventional clinical study (except observational studies or survival follow-up phase)
- Use of strong CYP3A4 inhibitors within 2 weeks or 5 half-lives before first study drug dose
- Anti-tumor therapy within 4 weeks or 5 half-lives before first study drug dose
- Therapeutic or palliative radiotherapy within 2 weeks before first study drug dose
- Biliary stenting or PTCD within 7 days before first study drug dose
- Planned other anti-tumor treatments during study (except palliative radiotherapy for symptom relief)
- Live vaccine within 4 weeks before or during study
- Major surgery or unhealed wounds, ulcers, or fractures within 4 weeks before first study drug dose
- Failure to recover to grade 0 or 1 adverse events prior to first dose (except certain conditions)
- History of gastrointestinal perforation or fistula within 6 months not resolved by surgery
- Presence of pyloric obstruction or persistent recurrent vomiting
- History of gastrointestinal or tracheal stenting
- Symptomatic central nervous system metastases
- Bone metastases at risk of paraplegia
- Interstitial lung disease needing steroid therapy or history of severe lung conditions
- Uncontrolled other primary malignancies
- Known immunodeficiency
- History of allogeneic organ transplantation or HSCT
- Prior treatment with antibody drug conjugates based on topoisomerase inhibitors
- Allergy or contraindication to study drugs
- Prior drug-related non-morbidity
- Pregnancy or lactation
- Other conditions deemed ineligible by investigators
AI-Screening
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Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
2
the First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Tingbo Liang, MD.
CONTACT
Y
Yiwen Chen, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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