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

Advanced or Metastatic Solid Tumors Clinical Trial

Official title:

A Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120 in Patients With Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234397
• Other study ID #: BH-BAFP-101
• Status: Recruiting
• Phase: Phase 1
• Start date: December 28, 2023
• Est. completion date: July 2027

Study information

• Verified date: January 2024
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Young Su (Bobby) Noh
• Phone: 82-2-410-9277
• Email: 63forever[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120 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 when administered at the RD to subjects in indication-specific expansion cohorts.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 191
• Est. completion date: July 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

• Subjects with CNS primary malignancies, active seizure disorder or spinal cord compression, or carcinomatous meningitis.

• 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.

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• BH3120
To evaluate the safety, tolerability, preliminary anti-tumor efficacy, PK and PD of BH3120 in solid tumors

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
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	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.	To evaluate safety and tolerability of BH3120 administration	Throughout the study until end of safety follow-up period (90 days after the last treatment)
Primary	Incidence and nature of DLTs	To evaluate safety and tolerability of BH3120 administration	At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
Secondary	The maximum serum concentration (Cmax)	To evaluate PK profile upon BH3120 administration	Throughout the study until treatment discontinuation (up to 2-3 years)
Secondary	The time to reach Cmax (Tmax)	To evaluate PK profile upon BH3120 administration	Throughout the study until treatment discontinuation (up to 2-3 years)
Secondary	The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)	To evaluate PK profile upon BH3120 administration	Throughout the study until treatment discontinuation (up to 2-3 years)
Secondary	The AUC during the dosing interval (AUCtau)	To evaluate PK profile upon BH3120 administration	Throughout the study until treatment discontinuation (up to 2-3 years)
Secondary	The AUC extrapolated to infinity (AUCinf)	To evaluate PK profile upon BH3120 administration	Throughout the study until treatment discontinuation (up to 2-3 years)
Secondary	The terminal half-life (T1/2)	To evaluate PK profile upon BH3120 administration	Throughout the study until treatment discontinuation (up to 2-3 years)
Secondary	The apparent clearance (CL/F)	To evaluate PK profile upon BH3120 administration	Throughout the study until treatment discontinuation (up to 2-3 years)
Secondary	The apparent volume of distribution (Vd/F)	To evaluate PK profile upon BH3120 administration	Throughout the study until treatment discontinuation (up to 2-3 years)
Secondary	Frequency of anti-drug antibodies (ADA)	Immunogenicity of BH3120	Throughout the study until treatment discontinuation (up to 2-3 years)
Secondary	Objective response rate (ORR)	ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Secondary	Disease Control Rate (DCR)	DCR will be measured as the proportion of subject with confirmed CR, PR, or Stable Disease (SD) as per RECIST v1.1	Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Secondary	Duration of response (DOR)	DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v. 1.1 or death from any cause, whichever occurs first.	Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Secondary	Progression-free survival (PFS)	PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v.1.1 or until death from any cause, whichever occurs first	Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)