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

Hanmi Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Advanced or Metastatic Solid Tumors

Treatments: Drug: BH3120; Drug: pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06234397

KEYNOTE-F89 (Other Identifier)

MK3475-F89 (Other Identifier)

BH-BAFP-101

Details and patient eligibility

About

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.

Enrollment: 245 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 2 patient groups

BH3120

Experimental group

Description:

Arm A: BH3120 Monotherapy

Treatment:

Drug: BH3120

BH3120 + pembrolizumab

Experimental group

Description:

Arm B: BH3120 in combination with pembrolizumab

Treatment:

Drug: pembrolizumab

Drug: BH3120