FS222 First in Human Study in Patients With Advanced Malignancies

Metastatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04740424
• Other study ID #: FS222-19101
• Status: Recruiting
• Phase: Phase 1
• Start date: December 14, 2020
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: invoX Pharma Limited
• Contact: invoX Clinical Trials
• Phone: +44 2038 820886
• Email: info[@]invoxpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 177
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Advanced Cancer
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
Georgia	Arensia Exploratory Medicine, LLC	Tbilisi
Romania	"Dr. Carol Davila" Nephrology Clinical Hospital	Bucharest
Romania	Prof. Dr. Alexandru Trestioreanu Oncologic Institute	Bucharest
Romania	Prof Dr I Chiricuta Institute of Oncology	Cluj-Napoca
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Institut Catala d'Oncologia de Badalona	Barcelona
Spain	NEXT - Hospital Quironsalud Barcelona	Barcelona
Spain	Complejo Hospitalario Universitario Insular-Materno Infantil	Las Palmas De Gran Canaria
Spain	Hospital Universitario 12 De Octubre	Madrid
Spain	Instituto de Investigación Sanitaria Fundación Jimenez Díaz	Madrid
Spain	NEXT - Hospital Universitario Quironsalud Madrid	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda
Spain	Clinica Universidad Navarra	Pamplona	Navarra
Spain	Universitary Hospital Virgen Macarena	Seville
Spain	Hospital Clinico Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
invoX Pharma Limited

Countries where clinical trial is conducted

Georgia,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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