Étude sur l'augmentation et l'expansion de la dose du BH3120 dans les tumeurs solides avancées ou métastatiques
Une étude de phase I, ouverte, multinationale, multicentrique, d'augmentation et d'expansion de la dose du BH3120 chez des patients atteints de tumeurs solides avancées ou métastatiques
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hyunmin (Dan) Lee
- Numéro de téléphone: 82-2-410-0470
- E-mail: Hyunmin.lee0607@hanmi.co.kr
Lieux d'étude
-
-
-
Seoul, Corée du Sud, 05505
- Recrutement
- Asan Medical Center
-
Seoul, Corée du Sud, 03080
- Recrutement
- Seoul National University Hospital
-
Seoul, Corée du Sud, 06351
- Recrutement
- Samsung Medical Center
-
Seoul, Corée du Sud, 03722
- Recrutement
- Severance Hospital
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Corée du Sud, 13620
- Recrutement
- Seoul National University Bundang Hospital
-
-
-
-
Florida
-
Tampa, Florida, États-Unis, 33612
- Recrutement
- Moffitt Cancer Center
-
-
Michigan
-
Grand Rapids, Michigan, États-Unis, 49546
- Recrutement
- The START Center for Cancer Care - Midwest
-
-
Ohio
-
Cincinnati, Ohio, États-Unis, 45219
- Recrutement
- Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center
-
-
Texas
-
Dallas, Texas, États-Unis, 75230
- Retiré
- Mary Crowley Cancer Research
-
San Antonio, Texas, États-Unis, 78229
- Recrutement
- Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Expérimental: 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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The maximum serum concentration (Cmax)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BH-BAFP-101
- KEYNOTE-F89 (Autre identifiant: Merck Sharp & Dohme LLC)
- MK3475-F89 (Autre identifiant: Merck Sharp & Dohme LLC)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .