Advanced CancerPhase 1NCT04740424
FS222 First in Human Study in Patients With Advanced Malignancies
A Phase 1 study testing FS222 in people with Advanced Cancer and Metastatic Cancer, run by invoX Pharma Limited at 21 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer
- What is being tested?
- FS222
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 21 sitesin 7 countries
- Study dates
- 14 Dec 2020to 30 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Participants with histologically or cytologically confirmed, locally advanced, unresectable or metastatic solid tumours for whom standard therapy has proven to be ineffective, intolerable or is considered inappropriate. This criterion does not apply to the PK/PD expansion cohort, where tumour-specific criteria will apply instead.
- No more than 1 line of prior therapy with ICB treatment. Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
- Participants who have received prior ICB, or any concurrent chemotherapy, radiotherapy, investigational, biologic or hormonal therapy for cancer treatment may be eligible for enrolment following a washout period.
- Participants who have received prior anti-PD-L1 therapy are eligible if PD-L1 therapy was discontinued ≥6 months prior to entry into the study.
- Participants who have failed a prior ICB regimen should document it.
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- Measurable disease. Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
- Eastern Cooperative Oncology Group Performance Status ≤1.
- The participant agrees to undergo a mandatory pre-treatment and on-treatment biopsy of the tumour. Certain exceptions apply.
- Highly effective contraception.
- Willing and able to provide written informed consent.
Who cannot join
- Participants with clinically relevant COVID-19 disease risk will be excluded from enrolment during the COVID-19 pandemic.
- Concurrent enrolment in another clinical study with the exception of non-interventional/observational studies or the follow-up period of an interventional study.
- Prior treatment with CD137 agonist mAb or other experimental agonists.
- For participants who have received prior ICB, participants must not have received more than 1 line of prior treatment with ICB(s). Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
- Participants with active autoimmune disease.
- Receipt of any live virus vaccine within 30 days prior to the first dose of study drug.
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- Receipt of a live attenuated vaccine within 30 days prior to the first dose of study drug.
- History of uncontrolled intercurrent illness.
- Psychological, familial, sociological or geographical conditions that do not permit compliance with the protocol.
- Judgment by the investigator that the participant is unsuitable to participate in the study, and the participant is unlikely to comply with study procedures, restrictions and requirements.
- Significant laboratory abnormalities.
- Known infections.
- Uncontrolled CNS metastases, primary CNS tumours with CNS metastases as only measurable disease. Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
- Prior history of any Grade ≥3 irAE that has not improved to Grade ≤1, except for endocrine deficiencies that are managed by HRT; significant treatment-related cytokine release syndrome; systemic inflammatory response syndrome.
- Current use of immunosuppressive agents, prior organ transplantation requiring immunosuppression, hypersensitivity or intolerance to mAb or their excipients, or persisting toxicity related to prior therapy of Grade >1 NCI CTCAE Version 5.0 .
Trial locations and contacts
21 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 7 countries
Spain12 sites, 12 recruiting
- Recruiting
NEXT - Hospital Quironsalud Barcelona
Barcelona, 08023
Guzman Alonso Casal, MD
- Recruiting
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Elena Garralda Cabanas, Ldo.
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Javier Garcia Corbacho, Ldo.
- Recruiting
Institut Catala d'Oncologia de Badalona
Barcelona, 08916
Marc Cucurull Salamero
- Recruiting
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, 35016
Delvys Rodriguez-Abreu, MD
- Recruiting
Instituto de Investigación Sanitaria Fundación Jimenez Díaz
Madrid, 28040
Victor Moreno, MD
- Recruiting
Hospital Universitario 12 De Octubre
Madrid, 28041
Gillermo de Velasco Oria de Rueda, Ldo.
- Recruiting
NEXT - Hospital Universitario Quironsalud Madrid
Madrid, 28050
Valentina Boni, MD
- Recruiting
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, 28222
Mariano Provencio Pulla, MD
- Recruiting
Clinica Universidad Navarra
Pamplona, Navarre, 31008
Ignacio Melero Bermejo, Ldo.
- Recruiting
Universitary Hospital Virgen Macarena
Seville, 41007
Teresa Garcia Manrique, MD
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Andrés Cervantes Ruiperez, Ldo.
Australia2 sites, 2 recruiting
- Recruiting
One Clinical Research Perth
Perth, Western Australia, 6150
Adnan Khattak, Dr
- Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Andre Van der Westhuizen, Dr
Poland2 sites, 2 recruiting
- Recruiting
MCM Krakow - PRATIA - PPDS
Krakow, 30-727
Anna Drosik-Kwasniewska, Dr
- Recruiting
Centrum Medyczne Poznan - PRATIA - PPDS
Poznan, Greater Poland Voivodeship, 60-780
Marek Kotlarski, Dr
Romania2 sites, 2 recruiting
- Recruiting
Prof. Dr. Alexandru Trestioreanu Oncologic Institute
Bucharest, 022322
Laurentia Nicoleta Gales, MD
- Recruiting
Prof Dr I Chiricuta Institute of Oncology
Cluj-Napoca, 400015
Tudor Ciuleanu, MD
Georgia1 site, 1 recruiting
- Recruiting
Arensia Exploratory Medicine, LLC
Tbilisi, 0112
Marina Maglakelidze, MD
Germany1 site, 1 recruiting
- Recruiting
SLK Kliniken Heilbronn GmbH
Heilbronn, Baden-Wurttemberg, 74078
Uwe Martens, Dr
Netherlands1 site, 1 recruiting
- Recruiting
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, 6525 GA
Carla van Herpen, Dr
About this study
Official title: 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
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
- Being tested
- FS222
- Keywords
- Immuno-oncology, bispecific antibody, dose escalation, cohort expansion, CD137, PD-L1, F-star, 4-1BB, Immunotherapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FS222Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| FS222 Q4W | Experimental | The initial cohorts will enroll sequentially as single participant cohorts. If no DLT or ≥Grade 2 study drug related adverse event is observed, then dosing will proceed in a 3+3 design. Additional participants will be recruited into the PK/PD expansion cohorts at dose levels deemed safe during dose escalation. Once a tolerated dose has been established participants will be recruited into tumour-specific expansion cohorts. Receives: Drug: FS222 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of adverse events (AEs) and serious adverse events (SAEs)
Safety and tolerability will be evaluated by collection of AEs and SAEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Measured: 15 months
Determination of a maximum tolerated dose (MTD) by evaluation of DLTs
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Measured: 28 days
Determination of a recommended Phase 2 dose (RP2D) by evaluation of DLTs
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start14 Dec 2020
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- invoX Pharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740424
- Sponsor's protocol ID
- FS222-19101
- Status last verified
- Jun 2025
- First submitted
- 28 Jan 2021
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04740424
- Acronym / sponsor ID
- FS222-19101
- Conditions
- Advanced Cancer, Metastatic Cancer
- Keywords
- Immuno-oncology, bispecific antibody, dose escalation, cohort expansion, CD137, PD-L1, F-star, 4-1BB
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- invoX Pharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FS222 Q4W | Experimental | Drug: FS222The initial cohorts will enroll sequentially as single participant cohorts. If no DLT or ≥Grade 2 study drug related adverse event is observed, then dosing will proceed in a 3+3 design. Additional participants will be recruited into the PK/PD expansion cohorts at dose levels deemed safe during dose escalation. Once a tolerated dose has been established participants will be recruited into tumour-specific expansion cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years.
- Participants with histologically or cytologically confirmed, locally advanced, unresectable or metastatic solid tumours for whom standard therapy has proven to be ineffective, intolerable or is considered inappropriate. This criterion does not apply to the PK/PD expansion cohort, where tumour-specific criteria will apply instead.
- No more than 1 line of prior therapy with ICB treatment. Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
- Participants who have received prior ICB, or any concurrent chemotherapy, radiotherapy, investigational, biologic or hormonal therapy for cancer treatment may be eligible for enrolment following a washout period.
- Participants who have received prior anti-PD-L1 therapy are eligible if PD-L1 therapy was discontinued ≥6 months prior to entry into the study.
Key exclusion criteria (15 listed)
- Participants with clinically relevant COVID-19 disease risk will be excluded from enrolment during the COVID-19 pandemic.
- Concurrent enrolment in another clinical study with the exception of non-interventional/observational studies or the follow-up period of an interventional study.
- Prior treatment with CD137 agonist mAb or other experimental agonists.
- For participants who have received prior ICB, participants must not have received more than 1 line of prior treatment with ICB(s). Exceptions as defined in protocol for PK/PD expansion cohorts will apply.
- Participants with active autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FS222Dosing of participants will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) until disease progression or unacceptable toxicity. | Drug | FS222 Q4W |
Primary outcome
Presence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 15 months
Safety and tolerability will be evaluated by collection of AEs and SAEs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Determination of a maximum tolerated dose (MTD) by evaluation of DLTs
Time frame: 28 days
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Determination of a recommended Phase 2 dose (RP2D) by evaluation of DLTs
Time frame: 28 days
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FS222 in people with Advanced Cancer and Metastatic Cancer, run by invoX Pharma Limited at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain, Australia, Poland, Romania, Georgia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact invoX Clinical Trials (+44 2038 820886, info@invoxpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of adverse events (AEs) and serious adverse events (SAEs) (time frame: 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.