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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle
Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGThe START Center for Cancer Care - Midwest
Grand Rapids, Michigan, United States
RECRUITINGCarl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
Cincinnati, Ohio, United States
RECRUITINGMary Crowley Cancer Research
Dallas, Texas, United States
WITHDRAWNMays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
San Antonio, Texas, United States
RECRUITINGSeoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGIncidence, 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
Time frame: 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
Time frame: At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
The maximum serum concentration (Cmax)
To evaluate PK profile upon BH3120 administration
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The time to reach Cmax (Tmax)
To evaluate PK profile upon BH3120 administration
Time frame: 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)
To evaluate PK profile upon BH3120 administration
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The AUC during the dosing interval (AUCtau)
To evaluate PK profile upon BH3120 administration
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The AUC extrapolated to infinity (AUCinf)
To evaluate PK profile upon BH3120 administration
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The terminal half-life (T1/2)
To evaluate PK profile upon BH3120 administration
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The apparent clearance (CL/F)
To evaluate PK profile upon BH3120 administration
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
The apparent volume of distribution (Vd/F)
To evaluate PK profile upon BH3120 administration
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
Frequency of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Immunogenicity of BH3120
Time frame: Throughout the study until treatment discontinuation (up to 2-3 years)
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
Time frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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
Time frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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.
Time frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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
Time frame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.