Trial intelligence / Profile preview

BL-M07D1 in First-line HER2-positive Breast Cancer

NCT06445400Phase 2

Key facts

Status: Active, not recruiting
Start: Jun 2024
Primary completion: Jul 2025
Countries: 1
Sponsor: Biokin Pharmaceutical
Modality: Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules

Drugs: BL-M07D1
Conditions: breast cancer

Overview

Phase 2, open-label trial of BL-M07D1 in breast cancer, sponsored by Biokin Pharmaceutical. Primary endpoints: Objective Response Rate at 24 months and Recommended Phase II Dose at 24 months. Started Jun 2024; status: active, not recruiting.

Design

1 arm

Study design: Open-label

Study treatment
Participants received BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+ Pertuzumab+Docetaxel in the first cycle (3 weeks).

Who it enrols

Adults aged 18-75 with unresectable locally advanced or metastatic HER2-positive breast cancer, ECOG 0-1, LVEF >= 50%, no prior systemic therapy for advanced disease, and no prior ADC with camptothecin derivative.

Endpoints

Primary

Objective Response Rate24 months
Recommended Phase II Dose24 months

Secondary

Progression-free Survival24 months
Disease Control Rate24 months
Duration of Response24 months
Treatment-Emergent Adverse Event24 months

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