Studio sull'escalation della dose e sull'espansione di BH3120 nei tumori solidi avanzati o metastatici
Uno studio di fase I, in aperto, multinazionale, multicentrico, con incremento ed espansione della dose di BH3120 in pazienti con tumori solidi avanzati o metastatici
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Hyunmin (Dan) Lee
- Numero di telefono: 82-2-410-0470
- Email: Hyunmin.lee0607@hanmi.co.kr
Luoghi di studio
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Seoul, Corea del Sud, 05505
- Reclutamento
- Asan Medical Center
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Seoul, Corea del Sud, 03080
- Reclutamento
- Seoul National University Hospital
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Seoul, Corea del Sud, 06351
- Reclutamento
- Samsung Medical Center
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Seoul, Corea del Sud, 03722
- Reclutamento
- Severance Hospital
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Corea del Sud, 13620
- Reclutamento
- Seoul National University Bundang Hospital
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Florida
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Tampa, Florida, Stati Uniti, 33612
- Reclutamento
- Moffitt Cancer Center
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Michigan
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Grand Rapids, Michigan, Stati Uniti, 49546
- Reclutamento
- The START Center for Cancer Care - Midwest
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- Reclutamento
- 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, Stati Uniti, 75230
- Ritirato
- Mary Crowley Cancer Research
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San Antonio, Texas, Stati Uniti, 78229
- Reclutamento
- Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Sperimentale: 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
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The maximum serum concentration (Cmax)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BH-BAFP-101
- KEYNOTE-F89 (Altro identificatore: Merck Sharp & Dohme LLC)
- MK3475-F89 (Altro identificatore: Merck Sharp & Dohme LLC)
Informazioni su farmaci e dispositivi, documenti di studio
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