A Study to Evaluate Safety and Tolerability of BPT567 in Patients With Advanced Solid Tumors
NCT ID: NCT06779851
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2024-10-15
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a Dose Escalation
Study drug BPT567 at multiple dose levels to define MTD or MAD
BPT567
Immunocytokine infusion
Phase 1b Dose Expansion
Study drug BPT567 at recommended dose for expansion (RDE) cohorts
BPT567
Immunocytokine infusion
Interventions
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BPT567
Immunocytokine infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Bright Peak Therapeutics Inc
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Honor Health Research Institute (HRI) Nurse Navigation
Role: primary
Role: backup
Julie Burns, BS
Role: primary
Oncology Clinical Research Referral Office
Role: primary
Dr. Neel Gandhi, MD
Role: primary
Anne Long, RN, BSN, OCN
Role: primary
Dr. Jason Luke
Role: primary
Isabel Jimenez Intake Specialist, RN, MSN
Role: primary
Other Identifiers
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BPT567-101
Identifier Type: -
Identifier Source: org_study_id