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2025-08
2027-08
2028-08
160
NCT07114315
Akeso
Akeso
INTERVENTIONAL
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.
N/A
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-08-03 | N/A | 2025-08-03 |
2025-08-03 | N/A | 2025-08-11 |
2025-08-11 | N/A | 2025-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: AK112 in combination with AK130 | DRUG: AK112
DRUG: AK130
|
| EXPERIMENTAL: AK112 | DRUG: AK112
DRUG: AK130
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1). | Through study completion, an average of 2 years |
| Duration of Response (DoR) | The time from first documented evidence of CR or PR until time of first documented disease progression. | 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) | Time between date of start of treatment until first documented response (CR or PR). | From date of randomization until the date of first documented response, assessed up to 24 months. |
| Progression Free Survival (PFS) | PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. | Through study completion, an average of 2 years. |
| Overall survival (OS) | OS is defined as the time from first dose until death due to any cause. | Through study completion, an average of 2 years. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Wenting Li Phone Number: +86 18116403289 Email: wenting01.li@akesobio.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
