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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Be able and willing to provide written willing to sign a consent form. - Have a expected to live at least 3 months. - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Subjects with diagnosed by tissue sample (biopsy-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 your organs (liver, kidneys, etc.) are working well enough based on blood tests. - 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). Who Should NOT Join This Trial: - 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. - previous cancer treatment that works throughout the body (like chemotherapy) 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

AK112

Following a predefined dose and date.

DRUG

AK130

Following a predefined dose and date.

Locations (2)

Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China