The purpose of this Phase 1/2 study is to test the overall safety, tolerability, and effectiveness of the combination investigational drugs evofosfamide, zalifrelimab, and balstilimab in treating advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, and human papilloma virus (HPV)-negative squamous cell carcinoma of the head and neck (SCCHN).
Histologically confirmed locally advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, or HPV-negative SCCHN for which no other lines of standard therapy with demonstrated clinical benefit are available or appropriate as treatment.
Appropriate to enter a clinical trial with a minimum estimated life expectancy of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
PSA progression: minimum of 2 rising values (3 measurements) obtained a minimum of 7 days apart with the last result being at least ≥4.0 ng/mL.
A history of currently active/uncontrolled autoimmune diseases or disorders, including inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, systemic sclerosis (scleroderma), systemic lupus erythematosus, or autoimmune vasculitis (eg, Wegener's granulomatosis).
Patients with prior history of any Grade 3 or Grade 4 AEs from anti-CTLA-4, anti-PD-1/PD-L1, or anti-CTLA-4 and anti-PD-1/PD-L-1 combination therapy.
History of acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal carcinomatosis, or other known risk factors for bowel perforation.
Patients on long-term systemic steroids (>10 mg daily prednisone equivalent initiated >2 weeks prior to study enrollment). Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
Sequential
Evofosfamide
DrugEvofosfamide administered on Days 1 and 8 of Cycles 1, 2, and 3.
Zalifrelimab
DrugZalifrelimab administered on Day 8 of Cycles 1, 3, and 5.
Balstilimab
DrugBalstilimab administered every 2 weeks beginning on Day 8 of Cycle 1.
Incidence and severity of adverse events including dose-limiting toxicities
Serious adverse events, discontinuations, and deaths
Progression-free survival per RECIST 1.1 and iRECIST
Objective response rate per RECIST 1.1 and iRECIST criteria (or PCWG3/RECIST for prostate cancer)
Duration of response per RECIST 1.1 and iRECIST
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ImmunoGenesis
Lead sponsor
Agenus Inc.
Collaborator
