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

NCT06779851 | Terminated Phase 1 FDA Drug

• 1 other identifier: BPT567-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Advanced Solid Tumors

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicity (DLT), Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)

  The MTD will be the highest tested dose of BPT567 at which protocol specified number of patients experience DLT or the MAD, highest administered dose in the absence of DLTs

  Duration of first cycle (28 Days) for each cohort evaluated

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Rate of subjects reporting adverse events or serious adverse events including abnormalities in safety laboratory results

  Through end of study (up to 2 years)

Secondary Outcomes (10)

• Pharmacokinetic parameter - Maximum Concentration (Cmax)

  Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)

• Pharmacokinetic parameter - Time to Maximumn Concentration (Tmax)

  Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)

• Pharmacokinetic parameter - Terminal Elimination Half-life (T1/2)

  Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)

• Pharmacokinetic parameter - Area under the plasma concentration curve up to the last quantifiable time-point ((AUC)0-last))

  Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)

• Pharmacokinetic parameter - Area area under the curve from 0 to infinite time (AUC0-inf)

  Cycle 1 (Days 1,2, 4, 8, 15 & 22) Cycles 2& 3 (Days 1&15) Cycles 4 & beyond (Day1) End of Treatment (up to 2 years)

Other Outcomes (1)

• Evaluate changes in immune cell composition and tumor genome.

  Through study completion up to 2 years

Study Arms (2)

Phase 1a Dose Escalation

EXPERIMENTAL

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

Drug: BPT567

Phase 1b Dose Expansion

EXPERIMENTAL

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

Drug: BPT567

Interventions

BPT567 DRUG

Immunocytokine infusion

Phase 1a Dose Escalation; Phase 1b Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Bright Peak Therapeutics Inc: lead

Study Sites (7)

Honor Health Research Institute

Scottsdale, Arizona, 85260, United States

Location

Start Midwest

Grand Rapids, Michigan, 49546, United States

Location

Hackensack Meridian John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

Location

Providence Cancer Institute

Portland, Oregon, 97213, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Ph1a Dose Escalation followed by and Ph 1b Dose Expansion study including multiple expansion cohorts

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 17, 2025
• Study Start: October 15, 2024
• Primary Completion: January 21, 2026
• Study Completion: March 11, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (7)