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RECRUITING
NCT06234397
PHASE1

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

Sponsor: Hanmi Pharmaceutical Company Limited

View on ClinicalTrials.gov

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.

Official title: A Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120, as a Single Agent and in Combination With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

245

Start Date

2023-12-28

Completion Date

2028-01

Last Updated

2026-03-11

Healthy Volunteers

No

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

Locations (10)

Moffitt Cancer Center

Tampa, Florida, United States

The START Center for Cancer Care - Midwest

Grand Rapids, Michigan, United States

Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center

Cincinnati, Ohio, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

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

San Antonio, Texas, United States

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea