Clinical Trial 23965

• Overview

  Study Title:

  A Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120, as a Single agent and in Combination with pembrolizumab, in Patients with Advanced or Metastatic Solid Tumors

  Summary:

  This is a study of an investigational drug called BH3120 as a possible treatment for advanced or metastatic solid tumors. In addition to BH3120, participants may also receive pembrolizumab. The main purpose of this study is to learn how safe and tolerable the study drug(s) are in participants with advanced or metastatic solid tumors.

  Objective:

  Primary Objective: * To evaluate the safety and tolerability of BH3120 administered intravenously (IV), as a single agent and in combination with pembrolizumab, in subjects with advanced or metastatic solid tumors Secondary Objectives: * To determine the MTD or RP2D of BH3120 administered, as a single agent and in combination with pembrolizumab, in subjects with advanced or metastatic solid tumors * To characterize the PK of BH3120, when administered intravenously as a single agent and in combination with pembrolizumab, in subjects with advanced or metastatic solid tumors * To assess the anti-tumor effect of BH3120 IV administration, as a single agent and in combination with pembrolizumab, in subjects with advanced or metastatic solid tumors

• Treatments

  Therapies:

  Bispecific Antibody; Immunotherapy

  Medications:

  BH3120 (); Pembrolizumab (Keytruda)

• Inclusion Criteria

  Key Inclusion Criteria:
  • 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.
  • Other criteria may apply

• Exclusion Criteria

  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.
  • Other exclusions may apply

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