A Study to Evaluate Safety and Tolerability of BPT567 in Patients With Advanced Solid Tumors

Eligibility Criteria

• * Male or female aged ≥18 years at the time of signing informed consent form
• * Measurable disease per RECIST 1.1
• * Histologically- or cytologically-diagnosed, locally advanced unresectable or metastatic solid tumor. Progressed or recurred after previously having received approved standard of care agents that are approved and available in their local geography.
• * ECOG Performance status of 0 or 1
• * Life expectancy of at least 3 months
• * Adequate organ and marrow function
• * Contraception during study participation, as applicable
• * Has received systemic small molecule therapy or radiation therapy within 28 days prior to the first dose.
• * Treatment with biologic agents including anti-PD-1 or PD-L1 antibodies for less than 6 weeks or 5 half-lives, whichever is shorter, prior to first dose.
• * Received any investigational agent less than 28 days or 5 half-lives, whichever is shorter, prior to the first dose.
• * Treatment with another IL-18 therapy.
• * Received systemic immunosuppressive agents greater than the equivalent of prednisone 10mg daily within 14 days of the study, though inhaled, intranasal, topical or intra-articular corticosteroids are allowed.
• * Certain clinically significant intercurrent disease.
• * Primary immune deficiency.
• * Active untreated brain or spine metastasis or leptomeningeal metastases.
• * Known HIV seroposivitiy, although patients treated for HIV with no detectable viral load for at least 1 month while on a stable regimen of agents are permitted.
• * Active hepatitis A or acute or chroming hepatitis B or C infection.
• * Received a live virus vaccine within 30 days of enrollment or a COVD vaccine within 14 days.