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NCT Number: NCT07114315

A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer

This is an open-label, multi-center phase II clinical study consisting of two parts:

Part I: To evaluate the safety and efficacy of AK130 combined with AK112 in advanced pancreatic cancer.

Part II: To evaluate the safety and efficacy of AK112, either as monotherapy or in combination with AK130, in advanced pancreatic cancer.

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai Municipality, China

Loading trial locations.

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.
  • Have a life expectancy of at least 3 months.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subjects with histologically or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC), who have progressed on ≤2 prior lines of systemic therapy.
  • According to RECIST v1.1, there is at least one measurable lesion.
  • Has adequate organ function.
  • All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 90 days after the last dose of study treatment.
  • Able to to comply with all requirements of study participation (including all study procedures).

Exclusion criteria

  • Except for PDAC, the subjects had other malignant tumors within the 5 years prior to enrollment.
  • There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.
  • There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
  • Prior systemic therapy with either TGF-β inhibitors or anti-angiogenic agents.
  • There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment.
  • History of severe bleeding tendency or coagulation dysfunction.
  • Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.
  • Pregnant or lactating female subject.

Treatment and study plan

AK112

Drug

Following a predefined dose and date.

AK130

Drug

Following a predefined dose and date.

Primary outcomes

  1. Number of subjects with adverse events (AEs)

    Time frame: From the time of informed consent signed through 30 days after the last dose of study drug or starting new anti-cancer therapy.

    AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.

  2. Objective Response Rate (ORR)

    Time frame: Through study completion, an average of 2 years

    ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).

Secondary outcomes

  1. Disease control rate (DCR)

    Time frame: Through study completion, an average of 2 years

    DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1).

  2. Duration of Response (DoR)

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

    The time from first documented evidence of CR or PR until time of first documented disease progression.

  3. Time to response (TTR)

    Time frame: From date of randomization until the date of first documented response, assessed up to 24 months.

    Time between date of start of treatment until first documented response (CR or PR).

  4. Progression Free Survival (PFS)

    Time frame: Through study completion, an average of 2 years.

    PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause.

  5. Overall survival (OS)

    Time frame: Through study completion, an average of 2 years.

    OS is defined as the time from first dose until death due to any cause.

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 Phase II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 11, 2025
Registry last updated
Mar 3, 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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