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

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and maximum tolerated dose (MTD) or maximum adminstered dose (MAD) of BPT567 in patients with advanced solid tumors, and establish the recommended dose for expansion cohorts.

Key facts

Study ID

NCT06779851

Run by

Bright Peak Therapeutics Inc

People needed

20

Starts

2024-10-15

Expected to finish

2026-03-11

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Honor Health Research Institute — Scottsdale, Arizona, United States
• Start Midwest — Grand Rapids, Michigan, United States
• Hackensack Meridian John Theurer Cancer Center — Hackensack, New Jersey, United States
• Carolina BioOncology Institute — Huntersville, North Carolina, United States
• Providence Cancer Institute — Portland, Oregon, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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