A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875

Summary

This is the first-in-human study with SYD1875, an antibody-drug conjugate (ADC) comprising of a humanized IgG1 monoclonal antibody directed against the 5T4 oncofetal antigen covalently conjugated to a duocarmycin-based linker-drug. This study includes a dose-escalation part (Part 1) in which the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts.

Timeline

Start

2020-02-28

Primary completion

2022-06-22

Completion

2023-01-26

Drugs

Indications