Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bright Peak Therapeutics Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
