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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BH3120 		Arm A: BH3120 Monotherapy
  • Drug: BH3120
    BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle
  • Drug: pembrolizumab
    Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
    Other names:
    • KEYTRUDA®
Experimental
BH3120 + pembrolizumab 		Arm B: BH3120 in combination with pembrolizumab
  • Drug: BH3120
    BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle
  • Drug: pembrolizumab
    Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
    Other names:
    • KEYTRUDA®

Recruiting Locations

Moffitt Cancer Center
Tampa, Florida 33612

The START Center for Cancer Care - Midwest
Grand Rapids, Michigan 49546

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

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

More Details

Status
Recruiting
Sponsor
Hanmi Pharmaceutical Company Limited

Study Contact

Young Su (Bobby) Noh
82-2-410-9277
63forever@hanmi.co.kr

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.