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

Not Applicable

Not yet recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: AK112; Drug: AK130

• Registration Number: NCT07114315
• Lead Sponsor: Akeso

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-03
• Study First Submitted QC: 2025-08-03
• Last Update Submitted: 2025-08-03
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2027-08
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Be able and willing to provide written informed consent.
2. Have a life expectancy of at least 3 months.
3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Subjects with histologically or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC), who have progressed on ≤2 prior lines of systemic therapy.
5. According to RECIST v1.1, there is at least one measurable lesion.
6. Has adequate organ function.
7. 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.
8. Able to to comply with all requirements of study participation (including all study procedures).

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK112 in combination with AK130	AK112	-
AK112 in combination with AK130	AK130	-
AK112	AK112	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events (AEs)	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.
Objective Response Rate (ORR)	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 Outcome Measures

Name	Time	Method
Disease control rate (DCR)	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).
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.	The time from first documented evidence of CR or PR until time of first documented disease progression.
Time to response (TTR)	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).
Progression Free Survival (PFS)	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.
Overall survival (OS)	Through study completion, an average of 2 years.	OS is defined as the time from first dose until death due to any cause.

Trial Locations

Locations (2)

Zhongshan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China