Etude : H3B-6545-A001-101 /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : H3B-6545-A001-101

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Thérapie ciblée

Cadre réglementaire : RIPH1

Dernière MÀJ : 30/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Essai de Phase I-II multicentrique en ouvert sur l'H3B-6545, un antagoniste covalent du récepteur alpha de l'oestrogène chez des femmes ayant un cancer du sein avec des récepteurs aux oestrogènes positifs, HER2-négatif, localement avancé ou métastatique.

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The purpose of phase 1 is to determine safety, tolerability and pharmacokinetics (PK) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer.

The purpose of phase 2 is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation [including a clonal estrogen receptor 1 gene (ESR1) Y537S mutation].

STUDY ARM:
- Experimental: H3B-6545 Arm 1: Dose escalation
- Experimental: H3B-6545 Arm 2: Phase 2

CURRENT PRIMARY OUTCOME:
- Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: Phase 1 Cycle 1 (28 days) ]
- Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Phase 1 and 2 continuously throughout the study until 28 days after treatment discontinuation (up to 36 months) ]

CURRENT SECONDARY OUTCOMES:
- Area under the Plasma Concentration-time Curve from Time 0 Through the Last Measurable Point (AUC0-t) of H3B-6545 [ Time Frame: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose ]
- Mean Maximum Observed Plasma Concentration (Cmax) of H3B-6545 [ Time Frame: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 (pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose ]
- Time of Maximum Observed Plasma Concentration (tmax) of H3B-6545 [ Time Frame: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose ]
- Objective Response Rate (ORR) [ Time Frame: Phase 1 and 2 up to approximately 36 months ]
- Duration of Response (DoR) [ Time Frame: Phase 1 and 2 up to approximately 36 months ]
- Disease Control Rate (DCR) [ Time Frame: Phase 1 and 2 up to approximately 36 months ]
- Clinical Benefit Rate (CBR) [ Time Frame: Phase 1 and 2 up to approximately 36 months ]
- Progression-free survival (PFS) [ Time Frame: Phase 1 and 2 up to approximately 36 months ]
- Overall Survival (OS) [ Time Frame: Phase 1 and 2 up to approximately 36 months ]

Phase : I/II

Stade : Localement avancé à Métastatique

2, 3, 4, X
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Pre- or post-menopausal women.
- ER-positive, HER2-negative breast cancer that is advanced or metastatic.
- Progressed on prior therapy. Multiple prior lines of therapy allowed in Phase 1 and 2. Participants under amendment 6 must have received prior cyclin-dependent kinase (CDK4/6) inhibitor therapy.
- A recent archival tumor tissue obtained within 6 months prior to enrollment or a fresh tumor biopsy must be provided. A second biopsy after initiating trial therapy is not required.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate bone marrow and organ function.
- Participants under amendment 6 must have measurable disease at baseline as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Participants under amendment 6 must have ESR1 Y537S mutation in absence of ESR1 D538G mutation as per the results of a central laboratory.

Critères de non-inclusion : - Participants must have at least one measurable lesion.
- Participant with inflammatory breast cancer.
- Participant has received more than one prior chemotherapy regimen for metastatic disease (Phase 2 only).
- Females of childbearing potential who are unable or unwilling to follow adequate contraceptive measures.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03250676
Promoteur :
H3 Biomedicine Inc.
Type de sponsor : Industriel
-
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Audrey MAILLIEZ

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Statut de l'essai : OUVERT

MAJ : 28/05/2021