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

Study Identifier:
BPT567-101
CT.gov Identifier:
NCT06779851
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study 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.

To assess the safety, antitumor activity, pharmacokinetics and pharmacodynamics of BPT567 in patients with locally advanced/unresectable or metastatic solid tumors

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase 1a Dose Escalation
    • Read More
  • Drug: Experimental: Phase 1b Dose Expansion
  • Drug: Intervention/Treatment
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor