AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer

NCT06646055 · tracked via the Priya Life Science China tracker

Sponsor

Akeso

Phase

Phase 1/2

Started

2025-01-21

Last updated

2026-03-09

Condition(s) studied

Metastatic Pancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

AK112, Cadonilimab, nab-paclitaxel, gemcitabineAK112, Cadonilimab, nab-paclitaxel, gemcitabineAK112, Cadonilimab, nab-paclitaxel, gemcitabineAK112, nab-paclitaxel, gemcitabinenab-paclitaxel, gemcitabine

AK112, Cadonilimab, nab-paclitaxel, gemcitabine: IV infusion, specified dose on specified days.

AK112, nab-paclitaxel, gemcitabine: IV infusion, specified dose on specified days.

nab-paclitaxel, gemcitabine: IV infusion, specified dose on specified days.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

Frequency of adverse events (AEs) and serious adverse events (SAEs) — 28days+28days
Frequency of AEs and SAEs for all Arms in phase Ib.
Overall Response Rate (ORR) — Up to approximately 2 years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

Trial sites (1)

Facility	City	Region	Status
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.	Wuhan	Hubei

More Akeso trials in China

A Phase Ib/II Clinical Study of AK127 in Combination With AK112 in Patients With Advanced Solid Tumors Active, not recruiting

A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer Recruiting

A Study of AK138D1 in Advanced Malignant Tumors Recruiting

A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects Starting soon

A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases Starting soon

Other trials for the same condition

A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma Recruiting

Chiauranib Plus PD-1 Inhibitor, Albumin-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Starting soon

Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules With Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Recruiting

Study of JAB-23E73 in Combination With Chemotherapy in Participants With Metastatic PDAC Harboring KRAS Gene Alterations Recruiting

Efficacy and Safety of Serplulimab in Combination With Bevacizumab and FOLFIRINOX or NALIRIFOX as Second-Line Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06646055 on ClinicalTrials.gov ↗ ← All trials in China