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Clinical Trial Summary

This study is being done for the following reasons:

- The study has two parts. The purpose of the first part (Phase 1a) of the study is to find out the highest dose of FS-1502 (Trastuzumab Monomethyl Auristatin F), an Anti-HER2 Antibody Drug Conjugate (ADC) that can be given safely.

- The purpose of the second part of the study (Phase 1b) is to observe the treatment effect of Recommended Phase 2 Dose (RP2D) of FS-1502 in patients with HER2+ breast cancer who are relapsed or refractory to the previous anti-HER2 therapy.

Clinical Trial Description

The study is designed as an open label, single arm, Phase 1a/1b study with a dose-escalation phase to evaluate FS-1502 in patients with HER2 expressed advanced malignant solid tumors (phase 1a) and an expanded cohort (phase 1b) to evaluate FS-1502 in patients with metastatic, HER2-positive breast cancer. The primary aim of the phase 1a portion of this study is to determine the safety and tolerability of FS-1502. The primary aim of the phase 1b portion is to demonstrate efficacy. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03944499
Study type Interventional
Source Shanghai Fosun Pharmaceutical Development Co, Ltd.
Contact BINGHE XU, PhD
Phone 010-87788826
Status Not yet recruiting
Phase Phase 1
Start date May 2019
Completion date June 2025

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