FS120 Phase 1/1b Study in Patients With Advanced Malignancies (NCT04648202)
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
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (11 items).
Location: Yale University — New Haven, Connecticut
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (9 Sites)
- Yale University — New Haven, Connecticut
- MD Anderson Cancer Center — Houston, Texas
- South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas
- Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah
- NEXT Oncology, Hospital Quironsalud Barcelona — Barcelona,
- Hospital Universitario Vall d'Hebron — Barcelona,
- Hospital Universitario Fundacion Jimenez Diaz — Madrid,
- Hospital Universitario 12 de Octubre — Madrid,
- Hospital Clinico Universitario de Valencia — Valencia,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.