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

Launched by BRIGHT PEAK THERAPEUTICS INC · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BPT567 for patients with advanced solid tumors, which are types of cancer that form lumps or masses in tissues. This is the first time BPT567 is being tested in humans. The main goals of the study are to find out how safe the treatment is, how well it works, and to determine the best dose for patients. The trial is currently looking for participants who are at least 18 years old, have been diagnosed with a specific type of advanced cancer that has not responded to previous treatments, and have a good performance status, meaning they are generally well enough to participate.

If you or a loved one decide to join the trial, you will undergo regular check-ups to monitor your health and how your body responds to the treatment. Participants will receive BPT567 and be closely observed for any side effects. It is important to note that there are certain criteria that might exclude someone from participating, such as recent cancer treatments or specific health conditions. Overall, this trial offers a chance to explore a new treatment option that could potentially help patients with advanced solid tumors.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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.