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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Advanced Cancer, Metastatic Cancer

Intervention / Treatment
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* Drug: FS120


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FS120<br>Open-label study where FS120 will be administered as monotherapy or in combination with pembrolizumab in dose escalation and expansion cohorts | Drug: FS120<br>* 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.<br>* Other names: Pembrolizumab (KEYTRUDA®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immuno-oncology, Bispecific antibody, Dose escalation, Cohort expansion, OX40, CD137 (4-1BB), invoX, Pembrolizumab, PD-1