Pancreatic Cancer
Conditions
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.
Interventions
DRUGAK112
Following a predefined dose and date.
DRUGAK130
Following a predefined dose and date.
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
CONTACTWenting Li
Outcome results
None listed