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FS222 First in Human Study in Patients With Advanced Malignancies

NCT04740424 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-07-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • invoX Pharma Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Australia
  • Georgia
  • Germany
  • Netherlands
  • Poland
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04740424 on ClinicalTrials.gov