FS120 Phase 1/1b Study in Patients With Advanced Malignancies

Metastatic Cancer Clinical Trial

Official title:

A Phase 1/1b Open-Label Study to Evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination With Pembrolizumab, in Subjects With Advanced Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04648202
• Other study ID #: FS120-19101
• Secondary ID: 2021-002820-19MK
• Status: Recruiting
• Phase: Phase 1
• Start date: November 18, 2020
• Est. completion date: March 1, 2026

Study information

• Verified date: July 2023
• 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 is a Phase 1/1b, multicenter, open label study to evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab, in Subjects with Advanced Malignancies

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 277
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Measurable disease

• Eastern Cooperative Oncology Group Performance Status 0-1.

• Highly effective contraception if risk of conception exists

• A female subject is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that uses highly effective contraception

• Subjects with HIV who are healthy and how a low risk of acquired immunodeficiency syndrome related outcomes

• For combination part: Subjects must have histologically confirmed locally advanced, unresectable or metastatic solid tumours where there is regulatory approval for use of pembrolizumab as a monotherapy agent

Exclusion Criteria:

• Prior systemic anticancer therapy within 28 days or 5- half-lives, whichever is shorter, before the first dose of study drug.

• Prior therapy with any OX40 agonist, CD137 (4-1BB) agonist, CD40 agonist, GITR, or CD27 targeting therapy (single agent or combination).

• Prior radiotherapy within 2 weeks of start of study treatment.

• HIV infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.

• Uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis, primary CNS tumours, or solid tumours with CNS metastases as the only measurable disease.

• Prior history of any grade =3 immune-related AE (irAE) that has not improved to grade =1; any grade =3 irAE that resulted in discontinuation of treatment, significant (grade =3 NCI CTCAE Version 5.0) treatment-related cytokine release syndrome.

• Use of immunosuppressive agents, hypersensitivity or intolerance to monoclonal antibodies or their excipients, persistent grade =1 NCI CTCAE Version 5 toxicity related to prior therapy or any condition that would significantly impair and/or prohibit the participant's participation in the study, as per the investigator's judgement.

• Vaccination with a live vaccine within 30 days before first dose of study drug.

• Participants with a known additional malignancy that is progressing or has required active treatment in the past 3 years.

• Participants with severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.

Related Conditions & MeSH terms

• Advanced Cancer
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• FS120
Dosing of participants with FS120 or the combination pembrolizumab will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) or once every 3 weeks (Q3W) until confirmed progressive disease (CPD)/immune-confirmed progressive disease (iCPD) or unacceptable toxicity.

Locations

Country	Name	City	State
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	NEXT Oncology, Hospital Quironsalud Barcelona	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Clinico Universitario de Valencia	Valencia
United States	MD Anderson Cancer Center	Houston	Texas
United States	Yale University	New Haven	Connecticut
United States	Huntsman Cancer Institute, University of Utah	Salt Lake City	Utah
United States	South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
invoX Pharma Limited	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs)	Safety and tolerability will be evaluated by collection of AEs, SAEs and DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.	24 months
Primary	Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)	Toxicity will be evaluated according to the NCI CTCAE Version 5.0.	24 months