Recruiting NCT07114315
A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK112, AK130.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
Overview
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.
Interventions
- Drug AK112
Following a predefined dose and date. - Drug AK130
Following a predefined dose and date.
Primary outcome measures
- 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.]
- Objective Response Rate (ORR) [Time frame: Through study completion, an average of 2 years]
Secondary outcome measures (5)
- Disease control rate (DCR) [Time frame: Through study completion, an average of 2 years]
- 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.]
- Time to response (TTR) [Time frame: From date of randomization until the date of first documented response, assessed up to 24 months.]
- Progression Free Survival (PFS) [Time frame: Through study completion, an average of 2 years.]
- Overall survival (OS) [Time frame: Through study completion, an average of 2 years.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Zhongshan Hospital Affiliated to Fudan University — Shanghai
- Tianjin Medical University Cancer Institute and Hospital — Tianjin
Identifiers
NCT: NCT07114315 · AK130-202