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NCT Number: NCT06646055

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.

Wuhan, Hubei, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
  • ≥18 years old and ≤ 75 years (regardless of sex).
  • ECOG performance status 0-1
  • Life expectancy longer than 3 months.
  • Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal carcinoma (PDAC).
  • No prior systemic anti-tumor therapy for metastatic PDAC.
  • Adequate organ function.
  • Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Exclusion criteria

  • Histological or cytological diagnosis of other pathological types.
  • BRCA1/2 or PALB2 mutations.
  • Participating in another clinical research.
  • Active central nervous system (CNS) metastases.
  • Undergoing systemic antiangiogenic therapy.
  • Acute or subacute pancreatitis.
  • Other known malignancies within five years.
  • Active infection requiring systemic therapy.

Treatment and study plan

AK112, Cadonilimab, nab-paclitaxel, gemcitabine

Drug

IV infusion, specified dose on specified days.

AK112, nab-paclitaxel, gemcitabine

Drug

IV infusion, specified dose on specified days.

nab-paclitaxel, gemcitabine

Drug

IV infusion, specified dose on specified days.

Primary outcomes

  1. Frequency of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: 28days+28days

    Frequency of AEs and SAEs for all Arms in phase Ib.

  2. Overall Response Rate (ORR)

    Time frame: Up to approximately 2 years

    ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.

Secondary outcomes

  1. Pharmacokinetics (PK)

    Time frame: Up to Cycle 12

    PK parameters: serum concentrations of AK112 and Cadonilimab at different point of time

  2. Anti-Drug Antibodies(ADAs)

    Time frame: Up to approximately 2 years

    Number and percentage of patients with detectable anti-drug antibodies

  3. Progression-Free Survival (PFS)

    Time frame: Up to approximately 2 years

    Evaluation of PFS based on RECIST v1.1.

  4. Overall survival (OS)

    Time frame: Up to approximately 2 years

    Evaluation of OS based on RECIST v1.1.

  5. Disease control rate (DCR)

    Time frame: Up to approximately 2 years

    Evaluation of DCR based on RECIST v1.1.

  6. Duration of Response (DoR)

    Time frame: Up to approximately 2 years

    Evaluation of DoR based on RECIST v1.1.

  7. Time to Response (TTR)

    Time frame: Up to approximately 2 years

    Evaluation of TTR based on RECIST v1.1.

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

A Phase Ib/II Clinical Study of AK112 and Cadonilimab Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 17, 2024
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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