Actively Recruiting
A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer
Led by Zhejiang University · Updated on 2025-09-23
64
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of IBI343 combined with chemotherapy in patients with advanced pancreatic cancer that tests positive for CLDN18.2. This phase II study includes two parts: Part 1 is a safety lead-in phase enrolling patients who may or may not have received prior systemic therapy, and Part 2 is an extension phase involving a randomized comparison. The study aims to better understand treatment options for this serious condition using a combination approach. In Part 1, patients receive IBI343 combined with an AG chemotherapy regimen consisting of albumin-bound paclitaxel and gemcitabine given by intravenous infusion on days 1 and 8 every 3 weeks. Dose adjustments will be made based on safety observations before moving to Part 2. In Part 2, 40 patients will be randomly assigned to two groups: Arm A will receive IBI343 plus gemcitabine and albumin-bound paclitaxel at doses to be determined, and Arm B will receive a standard chemotherapy regimen of gemcitabine and albumin-bound paclitaxel at fixed doses on days 1 and 8 every 3 weeks. Participants will be monitored for treatment response, side effects, and overall survival up to two years. Assessments include measuring tumors using imaging and tracking adverse events. The main outcomes are objective response rate and safety, with additional measures such as progression-free survival and duration of response. The study involves regular visits for treatment and evaluation, with ongoing monitoring to understand the effects of the combination therapy over time.
CONDITIONS
Brief Title
IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent and willingness to comply with study visits and procedures
- Histologically confirmed unresectable locally advanced, recurrent, or metastatic pancreatic adenocarcinoma
- Not eligible for radical treatments like surgery or radical radiotherapy
- For Part 1, may have received prior systemic therapy; for Part 2, no prior systemic therapy
- At least one measurable tumor lesion as defined by RECIST v1.1 criteria
- Age 18 years or older, any gender
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate bone marrow and organ function
- Use of effective contraception during and for 6 months after treatment for participants of childbearing potential
- Confirmed CLDN18.2 positive pathology
You will not qualify if you...
- Currently participating in another interventional clinical study or in survival follow-up phase of one
- Use of strong CYP3A4 inhibitors within 2 weeks or 5 half-lives before first study dose
- Anti-tumor therapy within 4 weeks or 5 half-lives before first study dose
- Therapeutic or palliative radiotherapy within 2 weeks prior to first study dose
- Biliary stenting or PTCD within 7 days before first study dose
- Planned other anti-tumor treatment during study medication, except for palliative radiotherapy for symptom relief
- Live vaccine administration within 4 weeks before or during study
- Major surgery within 4 weeks before first study dose or planned during study, excluding needle biopsy
- Unhealed wounds, ulcers, or fractures
- Failure to recover to grade 0 or 1 for certain adverse events before first dose
- History of unresolved gastrointestinal perforation or fistula within 6 months
- Presence of pyloric obstruction or recurrent vomiting
- After gastrointestinal or tracheal stenting
- Symptomatic central nervous system metastases; stable asymptomatic brain metastases allowed under strict conditions
- Bone metastases at risk of paraplegia
- Interstitial lung disease requiring steroids or history of severe lung problems
- Uncontrolled other primary malignancies
- Known immunodeficiency
- History of organ transplantation or stem cell transplant
- Prior treatment with topoisomerase inhibitor antibody drug conjugates
- History of allergy or contraindication to study drugs
- Pregnancy or lactation
- Other investigator-determined ineligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive IBI343 combined with gemcitabine and albumin-bound paclitaxel chemotherapy or gemcitabine plus albumin-bound paclitaxel chemotherapy alone according to their assigned study arm.
Visits on Days 1 and 8 of each 3-week cycle
Duration - Up to 2 years
Participants are monitored for safety and efficacy outcomes after treatment completion.
Regular follow-up visits as determined by the study team
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.
Y
Yiwen Chen, MD.
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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