A Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120 in Patients With Advanced or Metastatic Solid Tumors

Study Identifier:
BH-BAFP-101
CT.gov Identifier:
NCT06234397
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120 to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation part is planned to establish the MTD or RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120 when administered at the RD to subjects in indication-specific expansion cohorts.

The Dose-Expansion Part is designed to evaluate and confirm the safety, efficacy, pharmacokinetics, and pharmacodynamics of BH3120 when administered at the RD, with specific indications.

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
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: BH3120
    • Read More
  • Drug: Experimental: BH3120 + pembrolizumab
  • Drug: Drug: pembrolizumab
  • Drug: The study is composed of Dose-Escalation and Dose-Expansion Parts. Dose-Escalation Part is planned with a combination of accelerated titration design (ATD) and modified 3+3 design to establish the maximum tolerated dose (MTD) or recommended dose (RD) of BH3120 for the Dose-Expansion Part. ATD is used for the first two cohorts of the Dose-Escalation Part and is switched to modified 3+3 design thereafter. BH3120 is administered via intravenous infusion, once every 3 weeks (Q3W), starting at a dose of 0.1mg/kg, which may escalate up to 12mg/kg. During the Dose-Escalation part, to acquire additional safety and PD profiles of BH3120 for clear dose justification, Backfill and Exploratory Cohorts are planned.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Key
    • - Have a Histologically or cytologically confirmed non-CNS solid tumor that is
    • metastatic or unresectable and for whom there is no available standard therapy.
    • - PD-L1 positive expression (Tumor Proportion Score ≥1% or Combined Positive Score ≥1).
    • - Have at least one lesion, not previously irradiated that can be accurately measured
    • per RECIST version 1.1.
    • - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • - Age of 18 years or older (or country's legal age of majority if the legal age was >18
    • years)
    • - Adequate Hematologic and liver function.
    • Key
    Exclusion criteria
    • Has received prior therapy with an anti-4-1BB(CD137) agent.
    • Known active CNS metastases and/or carcinomatous meningitis.
    • Known additional malignancy that is progressing or has required active treatment.
    • History of chronic liver disease or evidence of hepatic cirrhosis.
    • History of severe toxicities associated with a prior immunotherapy.
    • Has ongoing or suspected autoimmune disease.
    • Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients.

    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
    Manish Sharma
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Solid Tumor