Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors

Description

This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, as a single agent and in combination with pembrolizumab, 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, as a single agent and in combination with pembrolizumab, when administered at the RD to subjects in indication-specific expansion cohorts.

Conditions

Advanced or Metastatic Solid Tumors

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Study Overview

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Study Details

Study overview

This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, as a single agent and in combination with pembrolizumab, 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, as a single agent and in combination with pembrolizumab, when administered at the RD to subjects in indication-specific expansion cohorts.

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

Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors

Condition
Advanced or Metastatic Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Cincinnati

Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center, Cincinnati, Ohio, United States, 45219

Dallas

Mary Crowley Cancer Research, Dallas, Texas, United States, 75230

San Antonio

Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hanmi Pharmaceutical Company Limited,

Study Record Dates

2028-01