A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: December 01, 2022
End Date: December 01, 2024
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.