FindTrial
Sign In

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

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06646055
Enrollment
110
Registered
2024-10-17
Start date
2025-01-21
Completion date
2027-12-30
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Brief 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.

Interventions

DRUGAK112, Cadonilimab, nab-paclitaxel, gemcitabine

IV infusion, specified dose on specified days.

DRUGAK112, nab-paclitaxel, gemcitabine

IV infusion, specified dose on specified days.

DRUGnab-paclitaxel, gemcitabine

IV infusion, specified dose on specified days.

Sponsors

Akeso
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Pharmacokinetics (PK)Up to Cycle 12PK parameters: serum concentrations of AK112 and Cadonilimab at different point of time
Anti-Drug Antibodies(ADAs)Up to approximately 2 yearsNumber and percentage of patients with detectable anti-drug antibodies
Progression-Free Survival (PFS)Up to approximately 2 yearsEvaluation of PFS based on RECIST v1.1.
Overall survival (OS)Up to approximately 2 yearsEvaluation of OS based on RECIST v1.1.
Disease control rate (DCR)Up to approximately 2 yearsEvaluation of DCR based on RECIST v1.1.
Duration of Response (DoR)Up to approximately 2 yearsEvaluation of DoR based on RECIST v1.1.
Time to Response (TTR)Up to approximately 2 yearsEvaluation of TTR based on RECIST v1.1.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026