Dosis-escalatie- en uitbreidingsstudie van BH3120 bij gevorderde of gemetastaseerde solide tumoren
Een fase I, open-label, multinationaal, multicenter, dosisescalatie- en uitbreidingsstudie van BH3120 bij patiënten met gevorderde of gemetastaseerde solide tumoren
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Hyunmin (Dan) Lee
- Telefoonnummer: 82-2-410-0470
- E-mail: Hyunmin.lee0607@hanmi.co.kr
Studie Locaties
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Florida
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Tampa, Florida, Verenigde Staten, 33612
- Werving
- Moffitt Cancer Center
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Michigan
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Grand Rapids, Michigan, Verenigde Staten, 49546
- Werving
- The START Center for Cancer Care - Midwest
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45219
- Werving
- 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, Verenigde Staten, 75230
- Ingetrokken
- Mary Crowley Cancer Research
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San Antonio, Texas, Verenigde Staten, 78229
- Werving
- Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
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Seoul, Zuid -Korea, 05505
- Werving
- Asan Medical Center
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Seoul, Zuid -Korea, 03080
- Werving
- Seoul National University Hospital
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Seoul, Zuid -Korea, 06351
- Werving
- Samsung Medical Center
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Seoul, Zuid -Korea, 03722
- Werving
- Severance Hospital
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Zuid -Korea, 13620
- Werving
- Seoul National University Bundang Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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 prior immunotherapy, except for adequately controlled endocrine-related adverse events managed with hormone replacement therapy.
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: BH3120
Arm A: BH3120 Monotherapy |
BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle |
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Experimenteel: BH3120 + pembrolizumab
Arm B: BH3120 in combination with pembrolizumab |
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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Tijdsspanne: Throughout the study until end of safety follow-up period (90 days after the last treatment)
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To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration |
Throughout the study until end of safety follow-up period (90 days after the last treatment)
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Incidence and nature of DLTs
Tijdsspanne: At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
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To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration |
At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The maximum serum concentration (Cmax)
Tijdsspanne: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon BH3120 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
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The time to reach Cmax (Tmax)
Tijdsspanne: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon BH3120 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
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The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)
Tijdsspanne: 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)
|
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The AUC during the dosing interval (AUCtau)
Tijdsspanne: 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)
|
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The AUC extrapolated to infinity (AUCinf)
Tijdsspanne: 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)
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The terminal half-life (T1/2)
Tijdsspanne: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon BH3120 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
|
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The apparent clearance (CL/F)
Tijdsspanne: 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)
|
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The apparent volume of distribution (Vd/F)
Tijdsspanne: 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)
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Frequency of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Tijdsspanne: 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)
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Objective response rate (ORR)
Tijdsspanne: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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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)
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Disease Control Rate (DCR)
Tijdsspanne: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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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)
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Duration of response (DOR)
Tijdsspanne: 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. |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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Progression-free survival (PFS)
Tijdsspanne: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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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)
|
Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BH-BAFP-101
- KEYNOTE-F89 (Andere identificatie: Merck Sharp & Dohme LLC)
- MK3475-F89 (Andere identificatie: Merck Sharp & Dohme LLC)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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