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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-28

Study Completion Date

2028-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced or Metastatic Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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BH3120

BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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KEYTRUDA®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No