- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06234397
Dose Escalation and Expansion Study of BH3120 in Advanced or Metastatic Solid Tumors
January 31, 2024 updated by: Hanmi Pharmaceutical Company Limited
A Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120 in Patients With Advanced or Metastatic Solid Tumors
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
191
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Young Su (Bobby) Noh
- Phone Number: 82-2-410-9277
- Email: 63forever@hanmi.co.kr
Study Locations
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-
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Seoul, Korea, Republic of, 03080
- Recruiting
- Seoul National University Hospital
-
Seoul, Korea, Republic of, 05505
- Recruiting
- Asan Medical Center
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Seoul, Korea, Republic of, 06351
- Recruiting
- Samsung Medical Center
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Seoul, Korea, Republic of, 03722
- Recruiting
- Severance Hospital
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- Recruiting
- Seoul National University Bundang Hospital
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-
-
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Not yet recruiting
- John Theurer Cancer Center at Hackensack University Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45219
- Not yet recruiting
- Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
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-
Texas
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Dallas, Texas, United States, 75230
- Recruiting
- Mary Crowley Cancer Research
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San Antonio, Texas, United States, 78229
- Not yet recruiting
- Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BH3120
BH3120 will be administered intravenously (IV) once every 3 weeks.
(Q3W)
|
To evaluate the safety, tolerability, preliminary anti-tumor efficacy, PK and PD of BH3120 in solid tumors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Time Frame: Throughout the study until end of safety follow-up period (90 days after the last treatment)
|
To evaluate safety and tolerability of BH3120 administration
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Throughout the study until end of safety follow-up period (90 days after the last treatment)
|
Incidence and nature of DLTs
Time Frame: At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
|
To evaluate safety and tolerability of BH3120 administration
|
At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The maximum serum concentration (Cmax)
Time Frame: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon BH3120 administration
|
Throughout the study until treatment discontinuation (up to 2-3 years)
|
The time to reach Cmax (Tmax)
Time Frame: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon BH3120 administration
|
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)
Time Frame: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon BH3120 administration
|
Throughout the study until treatment discontinuation (up to 2-3 years)
|
The AUC during the dosing interval (AUCtau)
Time Frame: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon BH3120 administration
|
Throughout the study until treatment discontinuation (up to 2-3 years)
|
The AUC extrapolated to infinity (AUCinf)
Time Frame: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon BH3120 administration
|
Throughout the study until treatment discontinuation (up to 2-3 years)
|
The terminal half-life (T1/2)
Time Frame: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon BH3120 administration
|
Throughout the study until treatment discontinuation (up to 2-3 years)
|
The apparent clearance (CL/F)
Time Frame: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon BH3120 administration
|
Throughout the study until treatment discontinuation (up to 2-3 years)
|
The apparent volume of distribution (Vd/F)
Time Frame: Throughout the study until treatment discontinuation (up to 2-3 years)
|
To evaluate PK profile upon BH3120 administration
|
Throughout the study until treatment discontinuation (up to 2-3 years)
|
Frequency of anti-drug antibodies (ADA)
Time Frame: Throughout the study until treatment discontinuation (up to 2-3 years)
|
Immunogenicity of BH3120
|
Throughout the study until treatment discontinuation (up to 2-3 years)
|
Objective response rate (ORR)
Time Frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
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)
|
Disease Control Rate (DCR)
Time Frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
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)
|
Duration of response (DOR)
Time Frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
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.
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Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
Progression-free survival (PFS)
Time Frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 28, 2023
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
January 8, 2024
First Submitted That Met QC Criteria
January 29, 2024
First Posted (Actual)
January 31, 2024
Study Record Updates
Last Update Posted (Estimated)
February 2, 2024
Last Update Submitted That Met QC Criteria
January 31, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BH-BAFP-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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