RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-15

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06779851

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Sujatha Venugopal Prasad, M. Sc.

CONTACT

+1(408)357- 4546

sprasad@brightpeaktx.com

Suba Krishnan, MD

CONTACT

skrishnan@brightpeaktx.com

Study Locations (Sites)

Honor Health Research Institute

Scottsdale, Arizona, 85260

United States

Start Midwest

Grand Rapids, Michigan, 49546

United States

Carolina BioOncology Institute

Huntersville, North Carolina, 28078

United States

Collaborators and Investigators

Sponsor: Bright Peak Therapeutics Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-15

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-10-15

Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

Solid Tumors

Additional Relevant MeSH Terms

Advanced Solid Tumors