Actively Recruiting
FS222 First in Human Study in Patients With Advanced Malignancies
Led by invoX Pharma Limited · Updated on 2025-07-01
260
Participants Needed
21
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
FS222 First in Human Study in Patients With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 618 years.
- Histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumors with ineffective, intolerable, or inappropriate standard therapy.
- No more than 1 prior line of immune checkpoint blockade (ICB) treatment, except as defined for PK/PD expansion cohorts.
- Prior ICB, chemotherapy, radiotherapy, investigational, biologic or hormonal cancer therapies allowed after washout period.
- Prior anti-PD-L1 therapy allowed if discontinued 6 months before study entry.
- Documented failure of prior ICB regimen.
- Presence of measurable disease, except as defined for PK/PD expansion cohorts.
- Eastern Cooperative Oncology Group Performance Status 61.
- Agreement to mandatory pre-treatment and on-treatment tumor biopsies, with some exceptions.
- Use of highly effective contraception.
- Willingness and ability to provide written informed consent.
You will not qualify if you...
- Clinically relevant COVID-19 disease risk during the pandemic.
- Concurrent enrollment in other interventional clinical studies, except non-interventional/observational or follow-up periods.
- Prior treatment with CD137 agonist monoclonal antibody or other experimental agonists.
- More than 1 prior line of ICB treatment, except as defined for PK/PD expansion cohorts.
- Active autoimmune disease.
- Receipt of live virus or live attenuated vaccine within 30 days prior to first study drug dose.
- History of uncontrolled intercurrent illness.
- Psychological, familial, sociological, or geographical conditions preventing protocol compliance.
- Investigator judgment deeming participant unsuitable or unlikely to comply.
- Significant laboratory abnormalities.
- Known infections.
- Uncontrolled CNS metastases or primary CNS tumors with CNS metastases as only measurable disease, except as defined for PK/PD expansion cohorts.
- Prior Grade 3 immune-related adverse events not improved to Grade 1, except managed endocrine deficiencies, significant cytokine release syndrome, or systemic inflammatory response syndrome.
- Current use of immunosuppressive agents, prior organ transplantation requiring immunosuppression, hypersensitivity or intolerance to monoclonal antibodies or excipients, or persisting toxicity related to prior therapy greater than Grade 1 (NCI CTCAE Version 5.0).
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 21 locations
1
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Actively Recruiting
2
One Clinical Research Perth
Perth, Western Australia, Australia, 6150
Actively Recruiting
3
Arensia Exploratory Medicine, LLC
Tbilisi, Georgia, 0112
Actively Recruiting
4
SLK Kliniken Heilbronn GmbH
Heilbronn, Baden-Wurttemberg, Germany, 74078
Actively Recruiting
5
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
6
Centrum Medyczne Poznan - PRATIA - PPDS
Poznan, Greater Poland Voivodeship, Poland, 60-780
Actively Recruiting
7
MCM Krakow - PRATIA - PPDS
Krakow, Poland, 30-727
Actively Recruiting
8
Prof. Dr. Alexandru Trestioreanu Oncologic Institute
Bucharest, Romania, 022322
Actively Recruiting
9
Prof Dr I Chiricuta Institute of Oncology
Cluj-Napoca, Romania, 400015
Actively Recruiting
10
Clinica Universidad Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
11
NEXT - Hospital Quironsalud Barcelona
Barcelona, Spain, 08023
Actively Recruiting
12
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
Actively Recruiting
13
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
14
Institut Catala d'Oncologia de Badalona
Barcelona, Spain, 08916
Actively Recruiting
15
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, Spain, 35016
Actively Recruiting
16
Instituto de Investigación Sanitaria Fundación Jimenez Díaz
Madrid, Spain, 28040
Actively Recruiting
17
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Actively Recruiting
18
NEXT - Hospital Universitario Quironsalud Madrid
Madrid, Spain, 28050
Actively Recruiting
19
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Spain, 28222
Actively Recruiting
20
Universitary Hospital Virgen Macarena
Seville, Spain, 41007
Actively Recruiting
21
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
I
invoX Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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