A Study to Evaluate Safety and Tolerability of BPT567 in Patients With Advanced Solid Tumors (SUMMIT-1)

Bright Peak Therapeutics Inc

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: BPT567

Study type: Interventional

Funder types: Industry

Identifiers

NCT06779851

BPT567-101

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Phase 1a Dose Escalation

Experimental group

Description:

Study drug BPT567 at multiple dose levels to define MTD or MAD

Treatment:

Drug: BPT567

Phase 1b Dose Expansion

Experimental group

Description:

Study drug BPT567 at recommended dose for expansion (RDE) cohorts

Treatment:

Drug: BPT567