Botensilimab + Chemotherapy for Pancreatic Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, certain treatments like cytotoxic agents, monoclonal antibodies, and small molecule therapies must be stopped within specific time frames before starting the study drugs.
What data supports the effectiveness of the drug Botensilimab + Chemotherapy for Pancreatic Cancer?
Research shows that combining nab-paclitaxel (a form of paclitaxel) with gemcitabine has significantly improved survival in patients with advanced pancreatic cancer compared to using gemcitabine alone. This suggests that the combination of these drugs can be effective in treating pancreatic cancer.12345
Is the combination of Botensilimab and chemotherapy safe for humans?
The combination of nab-paclitaxel (a form of paclitaxel) and gemcitabine has been studied for pancreatic cancer, showing it is generally safe for use in humans, including elderly patients. These drugs are FDA-approved for cancer treatment, and studies have shown they can be used together safely.12678
What makes the drug Botensilimab + Chemotherapy unique for pancreatic cancer?
The combination of Botensilimab with chemotherapy, including nab-paclitaxel and gemcitabine, is unique because nab-paclitaxel (a special formulation of paclitaxel) has shown improved survival rates in pancreatic cancer patients compared to gemcitabine alone, highlighting the importance of novel drug delivery technology in enhancing treatment efficacy.145910
What is the purpose of this trial?
This trial is testing whether adding a new drug, botensilimab, to standard chemotherapy can better treat patients with advanced pancreatic cancer. The study will ensure the new drug is safe and determine the right dose. It will also compare the effectiveness of the new combination treatment to chemotherapy alone.
Research Team
Medical Director
Principal Investigator
Agenus Inc.
Eligibility Criteria
This trial is for adults with metastatic pancreatic cancer who have already tried FOLFIRINOX treatment. They should be relatively healthy otherwise, with a life expectancy of at least 3 months and able to perform daily activities (ECOG status 0 or 1). Participants must not have other active cancers or serious illnesses, no history of severe allergies to study drugs, and agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-in
Participants receive botensilimab in combination with standard-of-care chemotherapy to establish safety and dose for Part 2
Treatment
Participants receive either botensilimab with chemotherapy or chemotherapy alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Botensilimab
- Gemcitabine
- Nab-paclitaxel
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Agenus Inc.
Lead Sponsor