A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer

March 2, 2026 updated by: Akeso

A Randomized, Controlled, Multi-center Phase III Clinical Study of Ivonescimab Plus Chemotherapy With or Without AK117 Versus Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer

This is a Phase 3, randomized, double-blind clinical trial aimed at evaluating the efficacy and safety of Ivonescimab plus chemotherapy with or without AK117 versus placebo plus chemotherapy in patients with metastatic pancreatic cancer. The study seeks to determine whether the addition of Ivonescimab and/or AK117 improves clinical outcomes compared to standard chemotherapy alone. Participants will be randomly assigned to receive either Ivonescimab with/without AK117 or placebo, both in combination with chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

999

Phase

  • Phase 3

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 Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 20032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntarily sign a written informed consent form.
  2. Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. Life expectancy of ≥ 3 months.
  5. Histologically or cytologically confirmed, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC).
  6. No prior systemic anti-cancer treatment for metastatic PDAC.
  7. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  8. Adequate organ function.

Exclusion Criteria:

  1. Histologically or cytologically confirmed other types of pancreatic malignancies or mixed histology types.
  2. Presence of active central nerve system (CNS) metastases.
  3. Known germline BRCA1/2 or PALB2 mutations.
  4. Clinically significant or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
  5. History of other malignancies within the past 5 years.
  6. History of significant bleeding tendencies or coagulopathy; clinically significant bleeding events within 1 month before the first dose.
  7. Previous anti-angiogenic therapy and immunotherapy.
  8. Active autoimmune disease requiring systemic treatment within the past 2 years.
  9. Pregnant or breastfeeding women.
  10. Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ivonescimab + AK117 + Albumin-bound Paclitaxel + Gemcitabine
Drug: Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine

Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV).

AK117: a specified dose and frequency administrated by intravenous infusion (IV).

Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest.

Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.
Experimental: Ivonescimab + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine
Drug: Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine

Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV).

AK117 Placebo: a specified dose and frequency administrated by intravenous infusion (IV).

Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest.

Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.
Active Comparator: Ivonescimab Placebo + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine
Drug: Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine

Ivonescimab Placebo : a specified dose and frequency administrated by intravenous infusion (IV).

AK117 Placebo : a specified dose and frequency administrated by intravenous infusion (IV).

Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest.

Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response (OS)
Time Frame: Up to approximately 2 years
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-drug antibodies (ADA)
Time Frame: Up to approximately 2 years
Number of subjects with detectable anti-drug antibodies (ADA).
Up to approximately 2 years
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
Time Frame: Up to approximately 2 years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1.
Up to approximately 2 years
Disease Control Rate (DCR) assessed by investigator per RECIST v1.1
Time Frame: Up to approximately 2 years
Disease control rate (DCR) assessed according to RECIST v1.1.
Up to approximately 2 years
Duration of response (DoR) assessed by the investigator per RECIST v1.1
Time Frame: Up to approximately 2 years
Duration of response (DoR) assessed according to RECIST v1.1.
Up to approximately 2 years
Time to response (TTR) assessed by the investigator per RECIST v1.1
Time Frame: Up to approximately 2 years
Time to response (TTR) is defined as the time to response based on RECIST v1.1.
Up to approximately 2 years
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
Time Frame: Up to approximately 2 years
PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1 criteria) assessed by investigators or death due to any cause, whichever occurs first.
Up to approximately 2 years
Cmax and Cmin
Time Frame: Up to approximately 2 years
AK112 serum drug concentrations in subjects at different time points after AK112 administration.
Up to approximately 2 years
Adverse Events (AEs)
Time Frame: Up to approximately 2 years
An AE is any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment.
Up to approximately 2 years

Collaborators and Investigators

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

Sponsor

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)

June 11, 2025

Primary Completion (Estimated)

May 14, 2027

Study Completion (Estimated)

May 14, 2028

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK112-310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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