Study on AGEN1423 and Botensilimab with or without Chemotherapy for Advanced Pancreatic Cancer
Sponsor: Bruno Bockorny
ClinicalTrials ID:NCT05632328
This clinical trial is testing the safety and effectiveness of combining the drugs AGEN1423 and Botensilimab, with or without chemotherapy, for treating advanced pancreatic cancer that has worsened after previous treatments.
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Program Overview
The purpose of this study is to evaluate if the combination of AGEN1423 and Botensilimab, with or without the chemotherapy drugs gemcitabine and nab-paclitaxel, is safe and effective for patients with advanced pancreatic ductal adenocarcinoma (PDAC) that has progressed after at least one prior cancer treatment. Participants will receive the study treatment for about 2 years and will be monitored for an additional year.
Description
This study involves testing a new treatment approach for advanced pancreatic cancer using the drugs AGEN1423 and Botensilimab, with or without chemotherapy. Participants will undergo screening to determine eligibility and will receive the study treatment for approximately 2 years, followed by a year of monitoring. If the treatment is found to be safe and shows positive results in at least two patients, the study will move to the next phase. This is a Phase II clinical trial, which means it is focused on assessing the safety and effectiveness of the treatment. The drugs AGEN1423 and Botensilimab are considered investigational, meaning they are still being studied and are not yet approved by the FDA for treating any disease. The pharmaceutical company Agenus is supporting this research by providing funding and the study drugs.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Able to understand and willing to sign a consent form.
- Have advanced pancreatic cancer that cannot be removed by surgery.
- Have at least one measurable tumor.
- Have previously received cancer treatment and shown progression.
- Willing to provide a fresh tumor sample if required.
- Have recovered from previous treatment side effects.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have a life expectancy of at least 3 months.
- Have adequate organ and blood function based on specific lab tests.
- Agree to use effective contraception during the study and for a period after the last dose of study medication.
Exclusion Criteria
- Have a type of pancreatic tumor other than adenocarcinoma.
- Have a bowel obstruction.
- Have received certain prior therapies like anti-PD-1 or anti-PD-L1 agents.
- Have an active or uncontrolled infection.
- Have a medical condition that would prevent participation.
- Have a disease that can be treated with curative intent.
- Are currently participating in another study or have recently received investigational treatment.
- Have a diagnosis of immunodeficiency or are on immunosuppressive therapy.
- Have had recent chemotherapy or radiation therapy and not recovered from side effects.
- Have an active autoimmune disease requiring treatment.
- Have a history of lung disease or low oxygen levels.
- Have recent heart problems or severe heart conditions.
- Have a condition that might interfere with the study results.
- Have psychiatric or substance abuse disorders affecting participation.
- Are pregnant, breastfeeding, or planning to conceive during the study.
- Have a positive HIV test unless on effective treatment.
- Have a history of chronic hepatitis B or C unless under control.
- Have active brain metastases or carcinomatous meningitis.
- Have received a live vaccine recently.
- Have frequent fluid drainage needs or a permanent drain.
- Have allergies to similar drugs as AGEN1423 or Botensilimab.
- Have another progressing or active cancer requiring treatment.
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