A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer
NCT ID: NCT05630183
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
81 participants
INTERVENTIONAL
2023-03-27
2025-12-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: Combination (Safety Lead-in Phase)
Participants will receive botensilimab in combination with standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
Botensilimab
A fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen 4 antibody administered intravenously.
Gemcitabine
Standard-of-care chemotherapy administered intravenously.
Nab-paclitaxel
Standard-of-care chemotherapy administered intravenously.
Part 2: Combination
Participants will receive botensilimab in combination standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
Botensilimab
A fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen 4 antibody administered intravenously.
Gemcitabine
Standard-of-care chemotherapy administered intravenously.
Nab-paclitaxel
Standard-of-care chemotherapy administered intravenously.
Part 2: Standard of Care
Participants will receive standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
Gemcitabine
Standard-of-care chemotherapy administered intravenously.
Nab-paclitaxel
Standard-of-care chemotherapy administered intravenously.
Interventions
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Botensilimab
A fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen 4 antibody administered intravenously.
Gemcitabine
Standard-of-care chemotherapy administered intravenously.
Nab-paclitaxel
Standard-of-care chemotherapy administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have had disease progression on any version of FOLFIRINOX for metastatic disease (including onivyde + oxaliplatin + 5-fluorouracil \[5-FU\] + leucovorin \[NALIRIFOX\]). Clarification: Participant with initial diagnosis of locally advanced disease may be eligible if upon retrospective review of initial scans, previously unappreciated metastases are able to be identified; Investigator must provide documentation that participant had metastatic disease at the time the participant received FOLFIRINOX. Notes: Progression on a reduced or maintenance fluoropyrimidine based regimen in the metastatic setting is allowed (for example, leucovorin + 5-FU + oxaliplatin \[FOLFOX\], leucovorin + 5-FU + irinotecan \[FOLFIRI\], 5-FU, or capecitabine), provided the participant received at least 1 dose of all of the drugs in a FOLFIRINOX regimen.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Life expectancy of at least 3 months.
* Measurable disease on baseline imaging per RECIST 1.1 criteria.
* A \< Grade 2 pre-existing peripheral neuropathy per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). Because NCI CTCAE v5.0 grading for peripheral neuropathy does not include guidance for "mild" neuropathy, these cases can be graded per the NCI CTCAE v5.0 grading for general adverse events which includes "mild" under Grade 1.
* Acceptable coagulation status as indicated by an international normalized ratio ≤ 1.5 x institutional ULN, except participants on anticoagulation who can be included at the discretion of the investigator.
* Adequate organ function.
* Women of childbearing potential must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study drugs).
* Male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study.
Exclusion Criteria
* History of central nervous system (CNS) metastasis or active CNS metastasis.
* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study drugs (that is, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years prior to first dose of study drugs and the participant has no evidence of disease). Participants with history of prior early-stage basal/squamous cell skin cancer or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.
* Uncontrolled intercurrent illness, including but not limited to clinically significant (that is, active) cardiovascular disease.
* Active, uncontrolled infections, requiring systemic intravenous anti-infective treatment within 2 weeks prior to first dose of study drugs.
* Major surgery within 4 weeks prior to signing of informed consent form (ICF).
* Prior treatment with an immune checkpoint inhibitor.
* Refractory ascites.
* Partial or complete bowel obstruction within the last 3 months prior to signing of ICF, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction.
* Clinically significant gastrointestinal disorders.
* Treatment with one of the following classes of drugs within the delineated time window prior to first dose of study drugs:
* Cytotoxic agent within 3 weeks or 5 half-lives (whichever is greater).
* Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or investigational drug, within 4 weeks, or 5 half-lives, whichever is shorter.
* Small molecule targeted therapies/tyrosine kinase inhibitors within 14 days or 5 half-lives (whichever is greater).
* Radiotherapy within 7 days.
* Previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to first dose of study drugs.
* Received a vaccine, including SARS-CoV-2 vaccine, \< 7 days prior to first dose of study drugs.
* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
* Symptomatic interstitial lung disease (ILD), history of ILD, or any lung disease which may interfere with detection and management of new immune-mediated pulmonary toxicity.
* History of allogeneic organ transplant.
* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
* Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 milligrams \[mg\] daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days prior to the first dose of study drugs. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent), are permitted in the absence of active autoimmune disease.
* Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years prior to first dose of study drugs (that is, with use of disease-modifying agents or immunosuppressive drugs).
* Pregnant or breastfeeding participants.
* Uncontrolled infection with human immunodeficiency virus.
* Known to be positive for hepatitis B (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection.
* Known active hepatitis C as determined by positive serology and confirmed by polymerase chain reaction.
* Dependence on total parenteral nutrition.
* Participants with concurrent diarrhea \> grade 1 at time of randomization despite optimal treatment with standard of care pancreatic enzymes.
* Known active or latent tuberculosis.
* Any condition in the opinion of the principal investigator that might interfere with the participant's participation in the study or in the evaluation of the study results.
* Unwillingness or inability to comply with procedures required in this protocol.
18 Years
ALL
No
Sponsors
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Agenus Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Agenus Inc.
Locations
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HonorHealth
Scottsdale, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
USC Norris Oncology
Newport Beach, California, United States
UCLA Health - Santa Monica Cancer Care
Santa Monica, California, United States
Medical Oncology Hematology Consultants (MOHC) - Helen F. Graham Cancer Center
Newark, Delaware, United States
Florida Cancer Specialist South
Fort Myers, Florida, United States
Cancer Care Centers of Brevard
Palm Bay, Florida, United States
Florida Cancer Specialist North
St. Petersburg, Florida, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Maryland Oncology Hematology
Columbia, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Rogel Cancer Center, University of Michigan Medicine
Ann Arbor, Michigan, United States
Minnesota Oncology
Minneapolis, Minnesota, United States
Nebraska Medicine-Nebraska Medical Center
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II*
Las Vegas, Nevada, United States
John Theurer Cancer Center at Hackensack
Hackensack, New Jersey, United States
Atlantic Health Systems, Morristown
Morristown, New Jersey, United States
Overlook Medical Center
Summit, New Jersey, United States
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medicine Sandra and Edward Meyer Cancer Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai Tisch Cancer Institute
New York, New York, United States
Oncology Hematology Care - Eastgate
Cincinnati, Ohio, United States
Sarah Cannon Research Institute at Tennessee Oncology
Cincinnati, Ohio, United States
Lifespan
Providence, Rhode Island, United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology
Carrollton, Texas, United States
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
TxO - Denison Cancer Center
Denison, Texas, United States
The Center for Cancer & Blood Disorders: Fort Worth
Fort Worth, Texas, United States
Northeast Texas Cancer & Research Institute
Tyler, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Virginia Oncology Associates - Brock Cancer Center
Norfolk, Virginia, United States
Shenandoah Oncology
Winchester, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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Other Identifiers
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C-800-22
Identifier Type: -
Identifier Source: org_study_id