Clinical trial · Interventional
Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is an Ib/II phase clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a second-line treatment for unresectable locally advanced or metastatic pancreatic cancer. Approximately 39-48 patients with unresectable locally advanced or metastatic pancreatic cancer, who have progressed on or are intolerant to first-line chemotherapy (albumin-bound paclitaxel + gemcitabine, AG regimen), will be enrolled. Treatment involves IBI363 combined with chemotherapy and continues until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons for discontinuation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI363 + chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Group
- interventionNames
- Drug: IBI363 + chemotherapy
Primary outcomes (2)
- measure
- Adverse events (AEs)
- timeFrame
- Up to approximately 36 months
- measure
- Progression-Free Survival(PFS)
- timeFrame
- Up to approximately 6 months
Secondary outcomes (3)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to approximately 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent form (ICF) * Age 18-75 years * Histologically/cytologically confirmed, unresectable locally advanced or metastatic pancreatic cancer. * Disease progression or intolerance after first-line treatment with the AG regimen (gemcitabine + albumin-bound paclitaxel). * ECOG Performance Status(PS) score of 0-1. * At least one measurable lesion according to RECIST v1.1 criteria. * Adequate organ and bone marrow function Exclusion Criteria: * Previous histologically/cytologically confirmed components including adenosquamous carcinoma, medullary carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, etc. * Prior treatment with PD-1/PD-L1 inhibitors or other immunotherapies. * Unresolved \> Grade 1 toxicities related to prior anticancer therapy (except persistent Grade 2 alopecia, anemia, peripheral neuropathy, correctable electrolyte abnormalities, or well-controlled endocrine disorders with hormone replacement therapy). * History of hepatic encephalopathy, seizures, active/new/untreated CNS metastases, spinal compression, carcinomatous meningitis, or leptomeningeal metastases. * Clinically significant cardiovascular/cerebrovascular diseases * Known hypersensitivity to IL-2, sintilimab, or monoclonal antibody components
References
Publications (0)
Data not yet available