Doseskalering och -expansionsstudie av BH3120 i avancerade eller metastatiska solida tumörer
En fas I, öppen, multinationell, multicenter, dosupptrappning och expansionsstudie av BH3120 hos patienter med avancerade eller metastaserande solida tumörer
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Hyunmin (Dan) Lee
- Telefonnummer: 82-2-410-0470
- E-post: Hyunmin.lee0607@hanmi.co.kr
Studieorter
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Florida
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Tampa, Florida, Förenta staterna, 33612
- Rekrytering
- Moffitt Cancer Center
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Michigan
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Grand Rapids, Michigan, Förenta staterna, 49546
- Rekrytering
- The START Center for Cancer Care - Midwest
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45219
- Rekrytering
- 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, Förenta staterna, 75230
- Indragen
- Mary Crowley Cancer Research
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San Antonio, Texas, Förenta staterna, 78229
- Rekrytering
- Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
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Seoul, Sydkorea, 05505
- Rekrytering
- Asan Medical Center
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Seoul, Sydkorea, 03080
- Rekrytering
- Seoul National University Hospital
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Seoul, Sydkorea, 06351
- Rekrytering
- Samsung Medical Center
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Seoul, Sydkorea, 03722
- Rekrytering
- Severance Hospital
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Rekrytering
- Seoul National University Bundang Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
|
Experimentell: 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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Tidsram: 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 |
Throughout the study until end of safety follow-up period (90 days after the last treatment)
|
|
Incidence and nature of DLTs
Tidsram: 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 |
At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The maximum serum concentration (Cmax)
Tidsram: 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)
|
|
The time to reach Cmax (Tmax)
Tidsram: 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)
|
|
The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)
Tidsram: 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)
|
|
The AUC during the dosing interval (AUCtau)
Tidsram: 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)
|
|
The AUC extrapolated to infinity (AUCinf)
Tidsram: 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)
|
|
The terminal half-life (T1/2)
Tidsram: 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)
|
|
The apparent clearance (CL/F)
Tidsram: 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)
|
|
The apparent volume of distribution (Vd/F)
Tidsram: 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)
|
|
Frequency of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Tidsram: 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)
|
|
Objective response rate (ORR)
Tidsram: 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 |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
|
Disease Control Rate (DCR)
Tidsram: 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 |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
|
Duration of response (DOR)
Tidsram: 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)
|
|
Progression-free survival (PFS)
Tidsram: 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 |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BH-BAFP-101
- KEYNOTE-F89 (Annan identifierare: Merck Sharp & Dohme LLC)
- MK3475-F89 (Annan identifierare: Merck Sharp & Dohme LLC)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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