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

March 5, 2026 updated by: Akeso

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xianglin Yuan, MD

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cadonilimab(q4w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)
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.
Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
IV infusion, specified dose on specified days.
Experimental: Cadonilimab(q2w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)
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.
Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
IV infusion, specified dose on specified days.
Experimental: Cadonilimab + AK112 + nab-paclitaxel + gemcitabine(phase II)
Cadonilimab will be administered at a selected dose and frequency from phase Ib. AK112 will be administered 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.
Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
IV infusion, specified dose on specified days.
Experimental: AK112 + nab-paclitaxel + gemcitabine(phase II)
AK112 will be administered 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.
Drug: AK112, nab-paclitaxel, gemcitabine
IV infusion, specified dose on specified days.
Active Comparator: nab-paclitaxel + gemcitabine(phase II)
Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
Drug: nab-paclitaxel, gemcitabine
IV infusion, specified dose on specified days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
28days+28days
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.
Up to approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK)
Time Frame: Up to Cycle 12
PK parameters: serum concentrations of AK112 and Cadonilimab at different point of time
Up to Cycle 12
Anti-Drug Antibodies(ADAs)
Time Frame: Up to approximately 2 years
Number and percentage of patients with detectable anti-drug antibodies
Up to approximately 2 years
Progression-Free Survival (PFS)
Time Frame: Up to approximately 2 years
Evaluation of PFS based on RECIST v1.1.
Up to approximately 2 years
Overall survival (OS)
Time Frame: Up to approximately 2 years
Evaluation of OS based on RECIST v1.1.
Up to approximately 2 years
Disease control rate (DCR)
Time Frame: Up to approximately 2 years
Evaluation of DCR based on RECIST v1.1.
Up to approximately 2 years
Duration of Response (DoR)
Time Frame: Up to approximately 2 years
Evaluation of DoR based on RECIST v1.1.
Up to approximately 2 years
Time to Response (TTR)
Time Frame: Up to approximately 2 years
Evaluation of TTR based on RECIST v1.1.
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akeso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AK112-210

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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