Combining AK112 and Cadonilimab with chemotherapy for treating advanced pancreatic cancer
A Phase Ib/II Clinical Study of AK112 and Cadonilimab Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer
This study is testing a new combination of two drugs, AK112 and Cadonilimab, with standard chemotherapy to see if it can help people with advanced pancreatic cancer who haven't had treatment before.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Akeso Industry-sponsored |
| Drugs / interventions | Cadonilimab, chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06646055 on ClinicalTrials.gov |
What this trial studies
This Phase Ib/II trial evaluates the safety and efficacy of a combination of AK112 and Cadonilimab with standard chemotherapy agents nab-paclitaxel and gemcitabine in patients with stage IV metastatic pancreatic ductal adenocarcinoma. Participants must be aged 18 to 75 with an ECOG performance status of 0-1 and a life expectancy of more than three months. The study aims to provide a new first-line treatment option for patients who have not received prior systemic therapy for their condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with confirmed metastatic pancreatic ductal carcinoma and an ECOG performance status of 0-1.
Not a fit: Patients with other types of cancer, active CNS metastases, or those who have received prior systemic therapy for metastatic PDAC may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for patients with metastatic pancreatic cancer.
How similar studies have performed: While the combination of these specific agents is being tested in this trial, similar approaches have shown promise in other studies involving chemotherapy and immunotherapy for pancreatic cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology. — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Wenting Li, MD
- Email: clinicaltrials@akesobio.com
- Phone: +86(0760)89873999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.