drugset / Trial / NCT04740424

FS222 First in Human Study in Patients With Advanced Malignancies

NCT04740424 ↗

Phase 1 Recruiting 260 enrolled invoX Pharma Limited
NaSingle-groupOpen-labelTreatment

Summary

This study will be conducted in adult participants diagnosed with advanced tumours to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS222. This is a Phase 1, multi-center, open label, multiple-dose, first in human study, designed to systematically assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS222 in participants with advanced tumours. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

Timeline

Start
2020-12-14
Primary completion
2027-10-30
Completion
2027-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject FS222 Monoclonal antibody — Intravenous