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Metastatic Pancreatic Ductal AdenocarcinomaPhase 1/2NCT06646055

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

A Phase 1/2 study testing AK112, Cadonilimab, nab-paclitaxel, gemcitabine, AK112, nab-paclitaxel, gemcitabine and nab-paclitaxel, gemcitabine in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Akeso at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
AK112, Cadonilimab, nab-paclitaxel, gemcitabine, AK112, nab-paclitaxel, gemcitabine and nab-paclitaxel, gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteChina
Study dates
21 Jan 2025to 30 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Wuhan, Hubei

Other trials in China

About this study

Official title: 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.

Being tested
AK112, Cadonilimab, nab-paclitaxel, gemcitabine, AK112, nab-paclitaxel, gemcitabine, nab-paclitaxel, gemcitabine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK112, Cadonilimab, nab-paclitaxel, gemcitabineDrug

    IV infusion, specified dose on specified days.

  • AK112, Cadonilimab, nab-paclitaxel, gemcitabineDrug

    IV infusion, specified dose on specified days.

  • AK112, Cadonilimab, nab-paclitaxel, gemcitabineDrug

    IV infusion, specified dose on specified days.

  • AK112, nab-paclitaxel, gemcitabineDrug

    IV infusion, specified dose on specified days.

  • nab-paclitaxel, gemcitabineDrug

    IV infusion, specified dose on specified days.

Study groups in NCT06646055
Study groupRoleWhat they receive
Cadonilimab(q4w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)ExperimentalCadonilimab 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.
Receives: Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
Cadonilimab(q2w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib)ExperimentalCadonilimab 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.
Receives: Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
Cadonilimab + AK112 + nab-paclitaxel + gemcitabine(phase II)ExperimentalCadonilimab 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.
Receives: Drug: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
AK112 + nab-paclitaxel + gemcitabine(phase II)ExperimentalAK112 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.
Receives: Drug: AK112, nab-paclitaxel, gemcitabine
nab-paclitaxel + gemcitabine(phase II)Active comparatorNab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively.
Receives: Drug: nab-paclitaxel, gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 28days+28days

  2. Overall Response Rate (ORR)

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

    Measured: Up to approximately 2 years

Secondary outcomes (7)

  1. Pharmacokinetics (PK)

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

    Measured: Up to Cycle 12

  2. Anti-Drug Antibodies(ADAs)

    Number and percentage of patients with detectable anti-drug antibodies

    Measured: Up to approximately 2 years

  3. Progression-Free Survival (PFS)

    Evaluation of PFS based on RECIST v1.1.

    Measured: Up to approximately 2 years

  4. Overall survival (OS)

    Evaluation of OS based on RECIST v1.1.

    Measured: Up to approximately 2 years

  5. Disease control rate (DCR)

    Evaluation of DCR based on RECIST v1.1.

    Measured: Up to approximately 2 years

  6. Duration of Response (DoR)

    Evaluation of DoR based on RECIST v1.1.

    Measured: Up to approximately 2 years

  7. Time to Response (TTR)

    Evaluation of TTR based on RECIST v1.1.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2024
  2. Study start21 Jan 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06646055
Sponsor's protocol ID
AK112-210
Status last verified
Mar 2026
First submitted
16 Oct 2024
Last updated
9 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK112, Cadonilimab, nab-paclitaxel, gemcitabine, AK112, nab-paclitaxel, gemcitabine and nab-paclitaxel, gemcitabine in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Akeso at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of adverse events (AEs) and serious adverse events (SAEs) (time frame: 28days+28days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06646055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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