NCT04740424

FS222 First in Human Study in Patients With Advanced Malignancies

A Phase 1, Open-Label, First-in-Human Study to Evaluate the Safety and Anti-tumour Activity of FS222, a CD137/PD-L1 Bispecific Antibody, in Subjects With Advanced Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: invoX Pharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	FS222	Dosing of participants will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) until disease progression or unacceptable toxicity.

Timeline

• Start date: 2020-12-14
• Primary completion: 2027-10-30
• Completion: 2027-10-30
• First posted: 2021-02-05
• Last updated: 2025-07-01

Locations

21 sites across 7 countries: Australia, Georgia, Germany, Netherlands, Poland, Romania, Spain