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

NCT07114315 | Recruiting Phase 2

• 1 other identifier: AK130-202
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Number of subjects with adverse events (AEs)

  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.

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

• Objective Response Rate (ORR)

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

  Through study completion, an average of 2 years

Secondary Outcomes (5)

• Disease control rate (DCR)

  Through study completion, an average of 2 years

• Duration of Response (DoR)

  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.

• Time to response (TTR)

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

• Progression Free Survival (PFS)

  Through study completion, an average of 2 years.

• Overall survival (OS)

  Through study completion, an average of 2 years.

Study Arms (2)

AK112 in combination with AK130

EXPERIMENTAL

Drug: AK112; Drug: AK130

AK112

EXPERIMENTAL

Drug: AK112

Interventions

AK112 DRUG

Following a predefined dose and date.

AK112; AK112 in combination with AK130

AK130 DRUG

Following a predefined dose and date.

AK112 in combination with AK130

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (2)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wenting Li

CONTACT

+86 18116403289; wenting01.li@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)