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NCT Number: NCT06953999

A Phase III Study of Ivonescimab + Chemo With/Without AK117 in 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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Histologically or cytologically confirmed other types of pancreatic malignancies or mixed histology types.
  • Presence of active central nerve system (CNS) metastases.
  • Known germline BRCA1/2 or PALB2 mutations.
  • Clinically significant or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
  • History of other malignancies within the past 5 years.
  • History of significant bleeding tendencies or coagulopathy; clinically significant bleeding events within 1 month before the first dose.
  • Previous anti-angiogenic therapy and immunotherapy.
  • Active autoimmune disease requiring systemic treatment within the past 2 years.
  • Pregnant or breastfeeding women.
  • 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.

Treatment and study plan

Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine

Drug

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.

Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine

Drug

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.

Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Cmax and Cmin

    Time frame: Up to approximately 2 years

    AK112 serum drug concentrations in subjects at different time points after AK112 administration.

  8. Anti-drug antibodies (ADA)

    Time frame: Up to approximately 2 years

    Number of subjects with detectable anti-drug antibodies (ADA).

Study contacts

Contact information is provided by the study sponsor or research team.

Wenting Li

CONTACT

[email protected]

+86-18116403289

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 1, 2025
Registry last updated
Mar 4, 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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