Safety and pharmacokinetics of MM-302, a HER2-targeted antibody-liposomal doxorubicin conjugate, in patients with advanced HER2-positive breast cancer: a phase 1 dose-escalation study.

ABSTRACT:

Background

This phase 1 dose-escalation trial studied MM-302, a novel HER2-targeted PEGylated antibody-liposomal doxorubicin conjugate, in HER2-positive locally advanced/metastatic breast cancer.

Methods

Patients were enrolled in four cohorts: MM-302 monotherapy (8, 16, 30, 40, and 50 mg/m² every 4 weeks [q4w]); MM-302 (30 or 40 mg/m² q4w) plus trastuzumab (4 mg/kg q2w); MM-302 (30 mg/m²) plus trastuzumab (6 mg/kg) q3w; MM-302 (30 mg/m²) plus trastuzumab (6 mg/kg) and cyclophosphamide (450 mg/m²) q3w.

Results

Sixty-nine patients were treated. The most common adverse events (AEs) were fatigue and nausea. Grade 3/4 AEs of special interest included neutropenia, fatigue, mucosal inflammation, anemia, thrombocytopenia,

SUBMITTER: Munster P 

PROVIDER: S-EPMC6219487 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature