ImmunoGenesis
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).
Tumor hypoxia can lead to poor effector T-cell penetration and immunosuppressive signaling via myeloid-derived suppressor cells, myofibroblasts, and regulatory T-cells. Disruption of these hypoxic regions within the tumor microenvironment by the hypoxia-directed cytotoxic agent evofosfamide may enhance the ability of immune checkpoint inhibitors to reject otherwise resistant solid tumors. The hypothesis tested in this study is that evofosfamide, by specifically targeting the hypoxic tumor microenvironment, may enhance the anti-tumor effects of the immune checkpoint inhibitors zalifrelimab (ant…
Inclusion Criteria: 1. 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. 2. Appropriate to enter a clinical trial with a minimum estimated life expectancy of at least 3 months. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 4. Measurable disease as defined by RECIST 1.1. Patients with castration-resistant prostate cancer can have measurable or evaluable disease…
Evofosfamide administered on Days 1 and 8 of Cycles 1, 2, and 3.
Zalifrelimab administered on Day 8 of Cycles 1, 3, and 5.
Balstilimab administered every 2 weeks beginning on Day 8 of Cycle 1.
Arctuva estimate
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