FS222 First in Human Study in Patients With Advanced Malignancies

June 26, 2025 updated by: invoX Pharma Limited

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Recruiting
        • Calvary Mater Newcastle
        • Principal Investigator:
          • Andre Van der Westhuizen, Dr
    • Western Australia
      • Perth, Western Australia, Australia, 6150
        • Recruiting
        • One Clinical Research Perth
        • Principal Investigator:
          • Adnan Khattak, Dr
  • Georgia
      • Tbilisi, Georgia, 0112
        • Recruiting
        • ARENSIA Exploratory Medicine, LLC
        • Contact:
          • Marina Maglakelidze, MD
  • Germany
    • Baden-Württemberg
      • Heilbronn, Baden-Württemberg, Germany, 74078
        • Recruiting
        • SLK Kliniken Heilbronn GmbH
        • Principal Investigator:
          • Uwe Martens, Dr
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Recruiting
        • Radboud Universitair Medisch Centrum
        • Principal Investigator:
          • Carla van Herpen, Dr
  • Poland
      • Kraków, Poland, 30-727
        • Recruiting
        • MCM Krakow - PRATIA - PPDS
        • Principal Investigator:
          • Anna Drosik-Kwasniewska, Dr
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 60-780
        • Recruiting
        • Centrum Medyczne Poznan - PRATIA - PPDS
        • Principal Investigator:
          • Marek Kotlarski, Dr
  • Romania
      • Bucharest, Romania, 022322
        • Recruiting
        • Prof. Dr. Alexandru Trestioreanu Oncologic Institute
        • Contact:
          • Laurentia Nicoleta Gales, MD
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • Prof Dr I Chiricuta Institute of Oncology
        • Contact:
          • Tudor Ciuleanu, MD
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Elena Garralda Cabanas, Ldo.
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
          • Javier Garcia Corbacho, Ldo.
      • Barcelona, Spain, 08023
        • Recruiting
        • NEXT - Hospital Quironsalud Barcelona
        • Contact:
          • Guzman Alonso Casal, MD
      • Barcelona, Spain, 08916
        • Recruiting
        • Institut Català d'Oncologia de Badalona
        • Contact:
          • Marc Cucurull Salamero
      • Las Palmas De Gran Canaria, Spain, 35016
        • Recruiting
        • Complejo Hospitalario Universitario Insular-Materno Infantil
        • Contact:
          • Delvys Rodriguez-Abreu, MD
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Gillermo de Velasco Oria de Rueda, Ldo.
      • Madrid, Spain, 28040
        • Recruiting
        • Instituto de Investigación Sanitaria Fundación Jimenez Díaz
        • Contact:
          • Victor Moreno, MD
      • Madrid, Spain, 28050
        • Recruiting
        • NEXT - Hospital Universitario Quironsalud Madrid
        • Contact:
          • Valentina Boni, MD
      • Majadahonda, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro - Majadahonda
        • Contact:
          • Mariano Provencio Pulla, MD
      • Seville, Spain, 41007
        • Recruiting
        • Universitary Hospital Virgen Macarena
        • Contact:
          • Teresa Garcia Manrique, MD
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
          • Andrés Cervantes Ruiperez, Ldo.
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Clinica Universidad Navarra
        • Contact:
          • Ignacio Melero Bermejo, Ldo.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FS222 Q4W
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
15 months
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.
28 days
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
invoX Pharma Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 14, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FS222-19101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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