NCT04648202

FS120 Phase 1/1b Study in Patients With Advanced Malignancies

A Phase 1/1b Open-Label Study to Evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination With Pembrolizumab, in Subjects With Advanced Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: invoX Pharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/1b, multicenter, open label study to evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab, in Subjects with Advanced Malignancies

Conditions

• Advanced Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	FS120	Dosing of participants with FS120 or the combination pembrolizumab will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) or once every 3 weeks (Q3W) until confirmed progressive disease (CPD)/immune-confirmed progressive disease (iCPD) or unacceptable toxicity.

Timeline

• Start date: 2020-11-18
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2020-12-01
• Last updated: 2025-06-27

Locations

9 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study