Clinical trial NCT06234397: Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors
Official title: A Phase I, Open-Label, Multinational, Multicenter, Dose Escalation and Expansion Study of BH3120, as a Single Agent and in Combination With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced or Metastatic Solid Tumors
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2024-01-31
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.
* 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.

Primary outcomes:
measure: Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
timeFrame: Throughout the study until end of safety follow-up period (90 days after the last treatment)
measure: Incidence and nature of DLTs
timeFrame: At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
Secondary outcomes:
measure: The maximum serum concentration (Cmax)
timeFrame: Throughout the study until treatment discontinuation (up to 2-3 years)
measure: The time to reach Cmax (Tmax)
timeFrame: Throughout the study until treatment discontinuation (up to 2-3 years)
measure: The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)
timeFrame: Throughout the study until treatment discontinuation (up to 2-3 years)
measure: The AUC during the dosing interval (AUCtau)
timeFrame: Throughout the study until treatment discontinuation (up to 2-3 years)
measure: The AUC extrapolated to infinity (AUCinf)
timeFrame: Throughout the study until treatment discontinuation (up to 2-3 years)
measure: The terminal half-life (T1/2)
timeFrame: Throughout the study until treatment discontinuation (up to 2-3 years)
measure: The apparent clearance (CL/F)
timeFrame: Throughout the study until treatment discontinuation (up to 2-3 years)
measure: The apparent volume of distribution (Vd/F)
timeFrame: Throughout the study until treatment discontinuation (up to 2-3 years)
measure: Frequency of anti-drug antibodies (ADA)
timeFrame: Throughout the study until treatment discontinuation (up to 2-3 years)
measure: Objective response rate (ORR)
timeFrame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
measure: Disease Control Rate (DCR)
timeFrame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
measure: Duration of response (DOR)
timeFrame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
measure: Progression-free survival (PFS)
timeFrame: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
state: Ohio
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: San Antonio
country: United States
facility: Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
state: Texas
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: