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

NCT06234397 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: BH-BAFP-101KEYNOTE-F89MK3475-F89
• Study Type: interventional
• Target: 245
• Locations: 2 countries
• Sites: 10

Brief 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

Outcome Measures

Primary Outcomes (2)

• Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.

  To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration

  Throughout the study until end of safety follow-up period (90 days after the last treatment)

• Incidence and nature of DLTs

  To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration

  At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part

Secondary Outcomes (13)

• The maximum serum concentration (Cmax)

  Throughout the study until treatment discontinuation (up to 2-3 years)

• The time to reach Cmax (Tmax)

  Throughout the study until treatment discontinuation (up to 2-3 years)

• The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)

  Throughout the study until treatment discontinuation (up to 2-3 years)

• The AUC during the dosing interval (AUCtau)

  Throughout the study until treatment discontinuation (up to 2-3 years)

• The AUC extrapolated to infinity (AUCinf)

  Throughout the study until treatment discontinuation (up to 2-3 years)

Study Arms (2)

BH3120

EXPERIMENTAL

Arm A: BH3120 Monotherapy

Drug: BH3120

BH3120 + pembrolizumab

EXPERIMENTAL

Arm B: BH3120 in combination with pembrolizumab

Drug: BH3120; Drug: pembrolizumab

Interventions

BH3120 DRUG

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

BH3120; BH3120 + pembrolizumab

pembrolizumab DRUG

Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle

Also known as: KEYTRUDA®

BH3120 + pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (10)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

The START Center for Cancer Care - Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

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

Cincinnati, Ohio, 45219, United States

RECRUITING

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

WITHDRAWN

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

San Antonio, Texas, 78229, United States

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Central Study Contacts

Young Su (Bobby) Noh

CONTACT

82-2-410-9277; 63forever@hanmi.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 31, 2024
• Study Start: December 28, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

KR (5); US (5)