AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC (NCT05632328)
A Phase 2 Study of AGEN1423, an Anti-CD73-TGFβ-Trap Bifunctional Antibody, in Combination With Botensilimab, With or Without Chemotherapy in Subjects With Advanced Pancreatic Cancer.
🩺 Plain-English Summary (8th-Grade Level)
The goal of this research study is to asses the safety and efficacy of the combination of AGEN1423 and Botensilimab with or without chemotherapies, gemcitabine and nab-paclitaxel, for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) which has progressed after at least one previous line of cancer therapy. The names of the study drugs involved in this study are: * AGEN1423 * Botensilimab Participants will receive study treatment for about 2 years and will be followed for 1 year after.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (34 items) and avoid the listed exclusions (26 items).
Location: Beth Israel Deaconess Medical Center — Boston, Massachusetts
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Has a pancreatic tumor other than adenocarcinoma, including: adenosquamous, acinar cell carcinoma, pancreaticoblastoma, malignant cystic neoplasms, endocrine neoplasms, squamous cell carcinoma, Vater and periampullary duodenal or common bile duct malignancies.
- Subjects with a bowel obstruction.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has an active infection requiring systemic therapy or has an uncontrolled infection.
- Has an underlying medical condition that would preclude study participation.
- Has a disease that is suitable for therapy administered with curative intent.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at Baseline) from AE due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or has not recovered (i.e., ≤ Grade 1 or at Baseline) from AE due to a previously administered agent (Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study. If subject underwent major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy)
- An active autoimmune disease that has required systemic treatment in the 2 years preceding the study (i.e., with the use of disease-modifying agents, corticosteroids or immuno-suppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: The names of the study drugs involved in this study are: * AGEN1423 * Botensilimab Participants will receive study treatment for about 2 years and will be followed for 1 year after.
More studies in Advanced Pancreatic Ductal Adenocarcinoma
Explore by condition: All Advanced Pancreatic Ductal Adenocarcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.