Clinical trial · Interventional
AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer
A Phase Ib/II Clinical Study of AK112 and Cadonilimab Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer
NCT06646055CI-TRIAL-00105053active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 trial is a Phase Ib/II study. All patients are stage IV pancreatic cancer (PDAC) patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The purpose of this study is to evaluate the safety and efficacy of AK112 and Cadonilimab combined with chemotherapy as first-line treatment for patients with metastatic pancreatic cancer.
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 |
|---|---|---|---|
| Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK112, Cadonilimab, nab-paclitaxel, gemcitabine | Drug | — | UNRESOLVED |
| AK112, nab-paclitaxel, gemcitabine | Drug | — | UNRESOLVED |
| nab-paclitaxel, gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cadonilimab(q4w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)
- description
- Cadonilimab will be administered at a selected dose every 4 weeks (q4w). AK112 will be administed at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
- interventionNames
- Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
- type
- EXPERIMENTAL
- label
- Cadonilimab(q2w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)
- description
- Cadonilimab will be administered at a selected dose every 2 weeks (q2w). AK112 will be administed at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
- interventionNames
- Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). 2. ≥18 years old and ≤ 75 years (regardless of sex). 3. ECOG performance status 0-1 4. Life expectancy longer than 3 months. 5. Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal carcinoma (PDAC). 6. No prior systemic anti-tumor therapy for metastatic PDAC. 7. Adequate organ function. 8. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Exclusion Criteria: 1. Histological or cytological diagnosis of other pathological types. 2. BRCA1/2 or PALB2 mutations. 3. Participating in another clinical research. 4. Active central nervous system (CNS) metastases. 5. Undergoing systemic antiangiogenic therapy. 6. Acute or subacute pancreatitis. 7. Other known malignancies within five years. 8. Active infection requiring systemic therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.