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New treatment option for Pancreatic Cancer
Official title A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT05859750
What this study is testing
What is AK104?
AK104 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multicenter, open-label, phase II study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activities of AK104，a PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy as first-line therapy in subjects with advanced unresectable or metastatic pancreatic ductal adenocarcinoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required...
- Males or females aged ≥ 18 years and ≤ 75 years at the time of signing the ICF.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).
- Patients have not received prior systemic therapy for locally advanced or metastatic pancreatic cancer; for patients who have received prior...
- Patients have at least one measurable tumor lesion per RECIST v1.1; lesions that received radiotherapy are not selected as target lesions, unless the...
You likely can't join if
- Histologically or cytologically confirmed other pathological types, such as acinar cell carcinoma, pancreatic neuroendocrine neoplasms or...
- Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease.
- Patients with known germ line BRAC1/2 mutation.
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
- Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease...
- Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors.
See the full eligibility criteria
- Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
- Males or females aged ≥ 18 years and ≤ 75 years at the time of signing the ICF.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).
- Patients have not received prior systemic therapy for locally advanced or metastatic pancreatic cancer; for patients who have received prior induction chemotherapy, concurrent chemoradiotherapy, or adjuvant/neoadjuvant...
- Patients have at least one measurable tumor lesion per RECIST v1.1; lesions that received radiotherapy are not selected as target lesions, unless the lesion is the only measurable lesion and has unequivocal progression...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival ≥ 3 months.
- Patients who have adequate organ function.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days...
- Histologically or cytologically confirmed other pathological types, such as acinar cell carcinoma, pancreatic neuroendocrine neoplasms or pancreatoblastoma.
- Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease.
- Patients with known germ line BRAC1/2 mutation.
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
- Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
- Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors.
- Major surgery other than the diagnosis of pancreatic cancer within 28 days prior to the first dose or major surgery is expected during the study.
- Pregnant or lactating women.
- Patients who received any prior treatments targeting the mechanism of tumor immunity.
- Patients with known contraindications to prescribed chemotherapy regimen (see instructions for specific drug).
- Patients with known medical history of severe hypersensitivity reactions to other monoclonal antibodies or intravenous gamma globulin.
- Active autoimmune disease within 2 years prior to the start of study treatmen.
- Known active pulmonary tuberculosis.
- Patients with active hepatitis B or active hepatitis C.
- Known medical history of immunodeficiency or positive HIV test.
- Patients with active infection.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Concurrent participation in another clinical study, unless it is an observational, non-treatment clinical study or the follow-up period of an treatment study.
- Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug, or would interfere with the evaluation of the study drug or the safety of patients, or the interpretation of...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Wuhan, Hubei, China; Jinan, Shandong, China; Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.