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

A Phase 1 Investigation of the Safety, Tolerability and Preliminary Antitumor Activity of BPT567, a Multifunctional PD1-IL18 Immunocytokine in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: BPT567

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Honor Health Research Institute
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • START Midwest
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Meridian John Theurer Cancer Center
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Carolina BioOncology Institute
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Cancer Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • South Texas Accelerated Research Therapeutics (START)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a Dose Escalation; Study drug BPT567 at multiple dose levels to define MTD or MAD	Drug: BPT567; Immunocytokine infusion
Experimental: Phase 1b Dose Expansion; Study drug BPT567 at recommended dose for expansion (RDE) cohorts	Drug: BPT567; Immunocytokine infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameter - Maximum Concentration (Cmax)	Maximum concentration of BPT567	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)	Time to maximum concentration of BPT567	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)	Terminal elimination half-life of BPT567	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))	(AUC)0-last of BPT567	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)	AUC0-inf of BPT567	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)
Anti-drug Antibody (ADA) Response to BPT567	Number of Participants With Anti-drug Antibody (ADA) Response to BPT567	Predose and postdose at multiple timepoints up to end of treatment (up to 2 years)
Objective response rate (ORR)	Per RECIST V1.1	Through study completion up to 2 years
Duration of response (DoR)	Per RECIST V1.1	Through study completion up to 2 years
Disease Control Rate (DCR)	Per RECIST V1.1	Through study completion up to 2 years
Progression Free Survival (PFS)	Per RECIST V1.1	Through study completion up to 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate changes in immune cell composition and tumor genome.	Peripheral blood and/or tumour biopsy specimens may be analysed in an exploratory manner to assess changes in immune cell composition through immunophenotyping and cytokine level measurements.	Through study completion up to 2 years

Collaborators and Investigators

• Sponsor: Bright Peak Therapeutics Inc

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): January 21, 2026
• Study Completion (Actual): March 11, 2026

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Solid Tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BPT567-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No