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

MC #23-23

NCT #
Condition(s)
Solid Tumor
Molecular Target(s)
4-1BB, PD-L1
Drug Classification(s)
Immunotherapy, Molecular Targeted Therapy
Agents(s)
BH3120
Phase(s)
I

Mechanism of Action

BH3120 is a PD-L1 x 4-1BB Bispecific Monoclonal Antibody

Purpose

In this study, the sponsor and investigators want to learn:
• How much of the study agent can be given with an acceptable level of side effects
• The effects of the study agent (good and bad)
• How much of the study agent is absorbed into the blood and how fast it is removed
• How the study agent is acting on your body

Study Design

This is a dose escalation/expansion study. Dose escalation means that the amount of the study agent given will be increased in each group of research participants, to find the most appropriate dose for further study. In the dose expansion part of the study, a larger number of people receive the study agent dose determined to be appropriate in the dose escalation part of the study.

The study regimen will be given in cycles. Each cycle is 3 weeks (21 days). You will receive the study agent once every 3 weeks as an intravenous (IV) infusion over 90 minutes. The volume of the study agent you will receive will depend on your body weight.

Location

Mary Crowley Cancer Research - Medical City Dallas

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