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.
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs) — 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.
Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) — 24 months Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Trial sites (9)
Facility
City
Region
Status
Yale University
New Haven
Connecticut
MD Anderson Cancer Center
Houston
Texas
South Texas Accelerated Research Therapeutics (START)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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