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Metastatic Pancreatic Ductal AdenocarcinomaPhase 2NCT05630183

A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer

A Phase 2 study testing Botensilimab, Gemcitabine and Nab-paclitaxel in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Agenus Inc. at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Botensilimab, Gemcitabine and Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
36 sitesUnited States
Study dates
27 Mar 2023to 5 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of pancreatic ductal adenocarcinoma. Note: fine needle aspirate/cytology of tumor in the presence of a pancreatic mass that confirms ductal adenocarcinoma is acceptable.
  • 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.
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  • 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.

Who cannot join

  • Received more than one prior regimen (that is, FOLFIRINOX) for their metastatic disease. (Progression on a reduced or maintenance fluoropyrimidine-based regimen in the metastatic setting is allowed. [for example, FOLFOX, FOLFIRI, 5-FU, or capecitabine], provided the participant received at least 1 dose of all of the drugs in a FOLFIRINOX regimen.)
  • 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).
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  • 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.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Rogel Cancer Center, University of Michigan Medicine

    Ann Arbor, Michigan, 48109

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Texas Oncology

    Carrollton, Texas, 75010

  • Oncology Hematology Care - Eastgate

    Cincinnati, Ohio, 45245

  • Sarah Cannon Research Institute at Tennessee Oncology

    Cincinnati, Ohio, 45245

  • Maryland Oncology Hematology

    Columbia, Maryland, 21044

  • Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75247

  • TxO - Denison Cancer Center

    Denison, Texas, 75020

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Florida Cancer Specialist South

    Fort Myers, Florida, 33901

  • The Center for Cancer & Blood Disorders: Fort Worth

    Fort Worth, Texas, 76104

  • John Theurer Cancer Center at Hackensack

    Hackensack, New Jersey, 07601

  • Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II*

    Las Vegas, Nevada, 89144

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Minnesota Oncology

    Minneapolis, Minnesota, 55404

  • Atlantic Health Systems, Morristown

    Morristown, New Jersey, 07960

  • Sarah Cannon Research Institute at Tennessee Oncology

    Nashville, Tennessee, 37203

  • Weill Cornell Medicine-New York Presbyterian Hospital

    New York, New York, 10021

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Weill Cornell Medicine Sandra and Edward Meyer Cancer Center

    New York, New York, 10065

  • Icahn School of Medicine at Mount Sinai Tisch Cancer Institute

    New York, New York, 10128

  • Medical Oncology Hematology Consultants (MOHC) - Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • USC Norris Oncology

    Newport Beach, California, 92663

  • Virginia Oncology Associates - Brock Cancer Center

    Norfolk, Virginia, 23502

  • Nebraska Medicine-Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Cancer Care Centers of Brevard

    Palm Bay, Florida, 32909

  • Lifespan

    Providence, Rhode Island, 02903

  • UCLA Health - Santa Monica Cancer Care

    Santa Monica, California, 90404

  • HonorHealth

    Scottsdale, Arizona, 85258

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Florida Cancer Specialist North

    St. Petersburg, Florida, 22705

  • Overlook Medical Center

    Summit, New Jersey, 07901

  • Northeast Texas Cancer & Research Institute

    Tyler, Texas, 75702

  • Shenandoah Oncology

    Winchester, Virginia, 22601

Other trials in United States

About this study

Official title: 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)

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.

Read the 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).

Being tested
Botensilimab, Gemcitabine, Nab-paclitaxel
Keywords
BOT, 1181, Immunotherapy, Pancreas, Gemcitabine, Nab-paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BotensilimabDrug

    Also called AGEN1181

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

  • GemcitabineDrug

    Standard-of-care chemotherapy administered intravenously.

  • Nab-paclitaxelDrug

    Standard-of-care chemotherapy administered intravenously.

Study groups in NCT05630183
Study groupRoleWhat they receive
Part 1: Combination (Safety Lead-in Phase)ExperimentalParticipants will receive botensilimab in combination with standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
Receives: Drug: Botensilimab; Drug: Gemcitabine; Drug: Nab-paclitaxel
Part 2: CombinationExperimentalParticipants will receive botensilimab in combination standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
Receives: Drug: Botensilimab; Drug: Gemcitabine; Drug: Nab-paclitaxel
Part 2: Standard of CareActive comparatorParticipants will receive standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival as Assessed by Investigator

    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 investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), or death, whichever occurs first.

    Measured: Up to 2 years

Secondary outcomes (7)

  1. Number of Participants with Treatment-emergent Adverse Events

    Measured: First study dose through up 1 year

  2. Overall Survival

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

    Measured: Up to 2 years

  3. Complete Response

    Complete response will be defined by RECIST 1.1 criteria and carbohydrate antigen 19-9 down to normal limits (from at least > 2 x upper limit of normal [ULN]). Cancer antigen 125 or carcinoembryonic antigen will be evaluated for non-expressors of carbohydrate antigen 19-9.

    Measured: Up to 2 years

  4. Overall Response Rate

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

    Measured: Up to 2 years

  5. Duration of Response

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

    Measured: Up to 2 years

  6. Change From Baseline in Carbohydrate Antigen 19-9

    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 non-expressors of carbohydrate antigen 19-9.

    Measured: Baseline, 2 years

  7. Rates of Normalization 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 > 2 x ULN). Cancer antigen 125 or carcinoembryonic antigen will be evaluated for non-expressors of carbohydrate antigen 19-9.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2022
  2. Study start27 Mar 2023
  3. Primary completion5 Jan 2026
  4. Study completion5 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05630183
Sponsor's protocol ID
C-800-22
Status last verified
Jun 2026
First submitted
18 Nov 2022
Last updated
11 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Botensilimab, Gemcitabine and Nab-paclitaxel in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Agenus Inc. at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival as Assessed by Investigator (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05630183.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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