Trial Title:
A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer
NCT ID:
NCT05630183
Condition:
Metastatic Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Paclitaxel
Gemcitabine
Conditions: Keywords:
BOT
1181
Immunotherapy
Pancreas
Gemcitabine
Nab-paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Botensilimab
Description:
A fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen
4 antibody administered intravenously.
Arm group label:
Part 1: Combination (Safety Lead-in Phase)
Arm group label:
Part 2: Combination
Other name:
AGEN1181
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Standard-of-care chemotherapy administered intravenously.
Arm group label:
Part 1: Combination (Safety Lead-in Phase)
Arm group label:
Part 2: Combination
Arm group label:
Part 2: Standard of Care
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Standard-of-care chemotherapy administered intravenously.
Arm group label:
Part 1: Combination (Safety Lead-in Phase)
Arm group label:
Part 2: Combination
Arm group label:
Part 2: Standard of Care
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed diagnosis of pancreatic ductal adenocarcinoma.
- Must have had disease progression on any version of FOLFIRINOX for metastatic
disease.
- 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.
- < Grade 2 pre-existing peripheral neuropathy per National Cancer Institute Common
Terminology Criteria for Adverse Events, Version 5.0.
- Acceptable coagulation status as indicated by an international normalized ratio ≤
1.5x 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:
- Received more than one prior regimen (that is, FOLFIRINOX) for their metastatic
disease.
- History of central nervous system 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 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.
- Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or
investigational drug, within 4 weeks, or 5 half-lives, whichever is shorter.
- Small molecule/tyrosine kinase inhibitors within 14 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.
- 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-related 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 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 (testing at screening not required).
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HonorHealth
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Erkut Borazanci
Email:
Principal Investigator
Facility:
Name:
USC Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Diana Hanna
Email:
Principal Investigator
Facility:
Name:
USC Norris Oncology
Address:
City:
Newport Beach
Zip:
92663
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Diana Hanna
Email:
Principal Investigator
Facility:
Name:
UCLA Health - Santa Monica Cancer Care
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Investigator:
Last name:
J. Randolph Hecht
Email:
Principal Investigator
Facility:
Name:
Medical Oncology Hematology Consultants (MOHC) - Helen F. Graham Cancer Center
Address:
City:
Newark
Zip:
19713
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jamal Misleh
Email:
Principal Investigator
Facility:
Name:
Florida Cancer Specialist South
Address:
City:
Fort Myers
Zip:
33901
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Syed Zafar
Email:
Principal Investigator
Facility:
Name:
Cancer Care Centers of Brevard
Address:
City:
Palm Bay
Zip:
32909
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Pavan Kancharla
Email:
Principal Investigator
Facility:
Name:
Florida Cancer Specialist North
Address:
City:
Saint Petersburg
Zip:
22705
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Maen Hussein
Email:
Principal Investigator
Facility:
Name:
Illinois Cancer Specialists
Address:
City:
Arlington Heights
Zip:
60005
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Richard Siegel
Email:
Principal Investigator
Facility:
Name:
Maryland Oncology Hematology
Address:
City:
Columbia
Zip:
21044
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Yousuf Gaffar
Email:
Principal Investigator
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Colin Weekes
Email:
Principal Investigator
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Andrea Bullock
Email:
Principal Investigator
Facility:
Name:
Rogel Cancer Center, University of Michigan Medicine
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Thomas Enzler
Email:
Principal Investigator
Facility:
Name:
Minnesota Oncology
Address:
City:
Minneapolis
Zip:
55404
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Timothy Larson
Email:
Principal Investigator
Facility:
Name:
Nebraska Medicine-Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Kelsey Klute
Email:
Principal Investigator
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II*
Address:
City:
Las Vegas
Zip:
89144
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Brian Vicuna
Email:
Principal Investigator
Facility:
Name:
John Theurer Cancer Center at Hackensack
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Martin Gutierrez
Email:
Principal Investigator
Facility:
Name:
Atlantic Health Systems, Morristown
Address:
City:
Morristown
Zip:
07960
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Angela Alistar
Email:
Principal Investigator
Facility:
Name:
Overlook Medical Center
Address:
City:
Summit
Zip:
07901
Country:
United States
Status:
Recruiting
Facility:
Name:
Weill Cornell Medicine-New York Presbyterian Hospital
Address:
City:
New York
Zip:
10021
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Pashtoon Kasi
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Investigator:
Last name:
Eileen O'Reilly
Email:
Principal Investigator
Facility:
Name:
Weill Cornell Medicine Sandra and Edward Meyer Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Pashtoon Kasi
Email:
Principal Investigator
Facility:
Name:
Icahn School of Medicine at Mount Sinai Tisch Cancer Institute
Address:
City:
New York
Zip:
10128
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Deirdre Cohen
Email:
Principal Investigator
Facility:
Name:
Oncology Hematology Care - Eastgate
Address:
City:
Cincinnati
Zip:
45245
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Mark Johns
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute at Tennessee Oncology
Address:
City:
Cincinnati
Zip:
45245
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Meredith Pelster
Email:
Principal Investigator
Facility:
Name:
Lifespan
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Alexander Raufi
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute at Tennessee Oncology
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Meredith Pelster
Email:
Principal Investigator
Facility:
Name:
Texas Oncology
Address:
City:
Carrollton
Zip:
75010
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Enrique Perez
Email:
Principal Investigator
Facility:
Name:
Baylor Charles A. Sammons Cancer Center
Address:
City:
Dallas
Zip:
75247
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Scott Paulson
Email:
Principal Investigator
Facility:
Name:
TxO - Denison Cancer Center
Address:
City:
Denison
Zip:
75020
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Amir Faridi
Email:
Principal Investigator
Facility:
Name:
The Center for Cancer & Blood Disorders: Fort Worth
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Henry Xiong
Email:
Principal Investigator
Facility:
Name:
Northeast Texas Cancer & Research Institute
Address:
City:
Tyler
Zip:
75702
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Donald Richards
Email:
Principal Investigator
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Investigator:
Last name:
M. Adham Salkeni
Email:
Principal Investigator
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Alex Spira
Email:
Principal Investigator
Facility:
Name:
Virginia Oncology Associates - Brock Cancer Center
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Yue Zhang
Email:
Principal Investigator
Facility:
Name:
Shenandoah Oncology
Address:
City:
Winchester
Zip:
22601
Country:
United States
Status:
Recruiting
Investigator:
Last name:
William Houck
Email:
Principal Investigator
Facility:
Name:
Swedish Cancer Institute
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Philip Gold
Email:
Principal Investigator
Start date:
March 27, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Agenus Inc.
Agency class:
Industry
Source:
Agenus Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05630183
