NCT05630183

A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer

A Randomized, Open-Label, Phase II Trial of Nab-paclitaxel + Gemcitabine With or Without Botensilimab (AGEN1181) in Patients With Metastatic Pancreatic Cancer Who Have Progressed on Prior 5FU + Leucovorin + Irinotecan + Oxaliplatin (FOLFIRINOX)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Agenus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test if the addition of botensilimab to standard chemotherapy improves the efficacy compared to just chemotherapy alone in participants with metastatic pancreatic cancer. One group of participants will only receive chemotherapy while a second group of participants will receive botensilimab and chemotherapy.

Detailed description

This will be a prospective, multicenter, clinical trial of botensilimab in combination with nab-paclitaxel + gemcitabine or nab-paclitaxel + gemcitabine alone. The trial will be conducted in 2 parts. Part 1 will be a safety lead-in to establish the safety and dose of botensilimab for Part 2. Part 2 will be a randomized, open-label assessment of botensilimab (at the dose level determined in Part 1).

Conditions

• Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Botensilimab	A fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen 4 antibody administered intravenously.
DRUG	Gemcitabine	Standard-of-care chemotherapy administered intravenously.
DRUG	Nab-paclitaxel	Standard-of-care chemotherapy administered intravenously.

Timeline

• Start date: 2023-03-27
• Primary completion: 2025-12-05
• Completion: 2025-12-05
• First posted: 2022-11-29
• Last updated: 2025-11-13

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study