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

invoX Pharma Limited9 sites in 2 countries82 target enrollmentNovember 18, 2020

ConditionsAdvanced Cancer Metastatic Cancer

InterventionsFS120

DrugsFS120

Overview

Phase: Phase 1
Intervention: FS120
Conditions: Advanced Cancer
Sponsor: invoX Pharma Limited
Enrollment: 82
Locations: 9
Primary Endpoint: Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
Status: Active, not recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

November 18, 2020

End Date

March 1, 2026

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

invoX Pharma Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Measurable disease
•Eastern Cooperative Oncology Group Performance Status 0-
•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.

Arms & Interventions

FS120

Open-label study where FS120 will be administered as monotherapy or in combination with pembrolizumab in dose escalation and expansion cohorts

Intervention: FS120

Outcomes

Primary Outcomes

Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)

Time Frame: 24 months

Toxicity will be evaluated according to the NCI CTCAE Version 5.0.

Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs)

Time Frame: 24 months

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.