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Participants will receive botensilimab in combination with standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).

Participants will receive botensilimab in combination standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).

Participants will receive standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).

A fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen 4 antibody administered intravenously.

Botensilimab

Standard-of-care chemotherapy administered intravenously.

Nab-paclitaxel

Agenus, Inc. Clinical Trial Information

Erkut Borazanci

Diana Hanna

J. Randolph Hecht

Jamal Misleh

Syed Zafar

Pavan Kancharla

Maen Hussein

Richard Siegel

Yousuf Gaffar

Colin Weekes

Andrea Bullock

Thomas Enzler

Timothy Larson

Kelsey Klute

Brian Vicuna

Martin Gutierrez

Angela Alistar

Pashtoon Kasi

Eileen O'Reilly

Deirdre Cohen

Mark Johns

Meredith Pelster

Alexander Raufi

Enrique Perez

Scott Paulson

Amir Faridi

Henry Xiong

Donald Richards

M. Adham Salkeni

Alex Spira

Yue Zhang

William Houck

Philip Gold

Medical Director

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.

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).

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)

Progression-free survival will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression, assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), or death, whichever occurs first.

Overall survival will be defined as the time from the date of randomization to the date of death due to any cause.

Complete response will be defined by RECIST 1.1 criteria and carbohydrate antigen 19-9 down to normal limits (from at least \> 2x upper limit of normal \[ULN\]). Cancer antigen 125 or carcinoembryonic antigen will be evaluated for participants who are not expressors of carbohydrate antigen 19-9.

Overall response rate will be defined as the proportion of participants whose best overall response is complete response or partial response per RECIST v1.1.

Duration of response will be defined as the time from the first determination of an objective response per RECIST v1.1, until the first documentation of progression or death, whichever occurs first.

Change in carbohydrate antigen 19-9 will be evaluated until progressive disease, death, date of last tumor assessment, or start of new anti-cancer therapy. Cancer antigen 125 or carcinoembryonic antigen will be evaluated for participants who are not expressors of carbohydrate antigen 19-9.

Carbohydrate antigen 19-9 normalization will be defined as a value of carbohydrate antigen 19-9 down to normal limits (from at least \> 2x ULN). Cancer antigen 125 or carcinoembryonic antigen will be evaluated for participants who are not expressors of carbohydrate antigen 19-9.

Agenus Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer	NCT05630183	Metastatic Panc...	Botensilimab Gemcitabine Nab-paclitaxel	18 Years -	Agenus Inc.
A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer	NCT05630183	Metastatic Panc...	Botensilimab Gemcitabine Nab-paclitaxel	18 Years -	Agenus Inc.

Spots Global Cancer Trial Database for 1181

Every month we try and update this database with for 1181 cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for 1181

Every month we try and update this database with for 1181 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 1181 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.