FS222 First in Human Study in Patients With Advanced Malignancies

NCT04740424 | Recruiting Phase 1

• 1 other identifier: FS222-19101
• Study Type: interventional
• Target: 260
• Locations: 7 countries
• Sites: 21

Brief 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

Advanced Cancer; Metastatic Cancer

Keywords

Immuno-oncology; bispecific antibody; dose escalation; cohort expansion; CD137; PD-L1; F-star; 4-1BB; Immunotherapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  28 days

Study Arms (1)

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.

Drug: FS222

Interventions

FS222 DRUG

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.

FS222 Q4W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• invoX Pharma Limited: lead

Study Sites (21)

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

RECRUITING

One Clinical Research Perth

Perth, Western Australia, 6150, Australia

RECRUITING

Arensia Exploratory Medicine, LLC

Tbilisi, 0112, Georgia

RECRUITING

SLK Kliniken Heilbronn GmbH

Heilbronn, Baden-Wurttemberg, 74078, Germany

RECRUITING

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Centrum Medyczne Poznan - PRATIA - PPDS

Poznan, Greater Poland Voivodeship, 60-780, Poland

RECRUITING

MCM Krakow - PRATIA - PPDS

Krakow, 30-727, Poland

RECRUITING

Prof. Dr. Alexandru Trestioreanu Oncologic Institute

Bucharest, 022322, Romania

RECRUITING

Prof Dr I Chiricuta Institute of Oncology

Cluj-Napoca, 400015, Romania

RECRUITING

Clinica Universidad Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

NEXT - Hospital Quironsalud Barcelona

Barcelona, 08023, Spain

RECRUITING

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Institut Catala d'Oncologia de Badalona

Barcelona, 08916, Spain

RECRUITING

Complejo Hospitalario Universitario Insular-Materno Infantil

Las Palmas de Gran Canaria, 35016, Spain

RECRUITING

Instituto de Investigación Sanitaria Fundación Jimenez Díaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

RECRUITING

NEXT - Hospital Universitario Quironsalud Madrid

Madrid, 28050, Spain

RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, 28222, Spain

RECRUITING

Universitary Hospital Virgen Macarena

Seville, 41007, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

invoX Clinical Trials

CONTACT

+44 2038 820886; info@invoxpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 5, 2021
• Study Start: December 14, 2020
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

AU (2); NL (1); DE (1); PL (2); GE (1); RO (2); ES (12)