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

NCT06234397 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2026-03-11

No results posted yet for this study

Summary

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-28
Primary Completion
2027-08-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06234397 on ClinicalTrials.gov