Dose Escalation and Expansion Study of BH3120 in Advanced or Metastatic Solid Tumors
- Conditions
- Advanced or Metastatic Solid Tumors
- Interventions
- Registration Number
- NCT06234397
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 191
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BH3120 + pembrolizumab pembrolizumab Arm B: BH3120 in combination with pembrolizumab BH3120 BH3120 Arm A: BH3120 Monotherapy BH3120 + pembrolizumab BH3120 Arm B: BH3120 in combination with pembrolizumab
- Primary Outcome Measures
Name Time Method Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0. Throughout the study until end of safety follow-up period (90 days after the last treatment) To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration
Incidence and nature of DLTs At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration
- Secondary Outcome Measures
Name Time Method The terminal half-life (T1/2) Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon BH3120 administration
Frequency of anti-drug antibodies (ADA) Throughout the study until treatment discontinuation (up to 2-3 years) Immunogenicity of BH3120
The maximum serum concentration (Cmax) Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon BH3120 administration
The time to reach Cmax (Tmax) Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon BH3120 administration
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) To evaluate PK profile upon BH3120 administration
The AUC during the dosing interval (AUCtau) Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon BH3120 administration
The AUC extrapolated to infinity (AUCinf) Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon BH3120 administration
The apparent volume of distribution (Vd/F) Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon BH3120 administration
Objective response rate (ORR) 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
The apparent clearance (CL/F) Throughout the study until treatment discontinuation (up to 2-3 years) To evaluate PK profile upon BH3120 administration
Progression-free survival (PFS) 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
Disease Control Rate (DCR) 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
Duration of response (DOR) 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.
Trial Locations
- Locations (8)
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, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of