Studie eskalace a expanze dávky BH3120 u pokročilých nebo metastatických pevných nádorů
Fáze I, otevřená, nadnárodní, multicentrická studie eskalace a expanze dávky BH3120 u pacientů s pokročilými nebo metastatickými solidními nádory
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: Hyunmin (Dan) Lee
- Telefonní číslo: 82-2-410-0470
- E-mail: Hyunmin.lee0607@hanmi.co.kr
Studijní místa
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Seoul, Jižní Korea, 05505
- Nábor
- Asan Medical Center
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Seoul, Jižní Korea, 03080
- Nábor
- Seoul National University Hospital
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Seoul, Jižní Korea, 06351
- Nábor
- Samsung Medical Center
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Seoul, Jižní Korea, 03722
- Nábor
- Severance Hospital
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Jižní Korea, 13620
- Nábor
- Seoul National University Bundang Hospital
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Florida
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Tampa, Florida, Spojené státy, 33612
- Nábor
- Moffitt Cancer Center
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Michigan
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Grand Rapids, Michigan, Spojené státy, 49546
- Nábor
- The START Center for Cancer Care - Midwest
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Ohio
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Cincinnati, Ohio, Spojené státy, 45219
- Nábor
- 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, Spojené státy, 75230
- Staženo
- Mary Crowley Cancer Research
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San Antonio, Texas, Spojené státy, 78229
- Nábor
- Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Experimentální: 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
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Časové okno: 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
Časové okno: 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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The maximum serum concentration (Cmax)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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 AUC during the dosing interval (AUCtau)
Časové okno: 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 AUC extrapolated to infinity (AUCinf)
Časové okno: 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 terminal half-life (T1/2)
Časové okno: 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)
Časové okno: 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 volume of distribution (Vd/F)
Časové okno: 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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Frequency of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Časové okno: Throughout the study until treatment discontinuation (up to 2-3 years)
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Immunogenicity of BH3120 |
Throughout the study until treatment discontinuation (up to 2-3 years)
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Objective response rate (ORR)
Časové okno: 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)
Časové okno: 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)
Časové okno: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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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)
Časové okno: 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)
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BH-BAFP-101
- KEYNOTE-F89 (Jiný identifikátor: Merck Sharp & Dohme LLC)
- MK3475-F89 (Jiný identifikátor: Merck Sharp & Dohme LLC)
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