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A Phase 1/2, Open-Label, Study to Evaluate the Safety and Anti-Tumor Activity of FS118, a LAG-3/PD-L1 Bispecific Antibody, as a Monotherapy and in Combination With Paclitaxel, in Patients With Advanced Malignancies

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Trial Profile

A Phase 1/2, Open-Label, Study to Evaluate the Safety and Anti-Tumor Activity of FS118, a LAG-3/PD-L1 Bispecific Antibody, as a Monotherapy and in Combination With Paclitaxel, in Patients With Advanced Malignancies

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 08 Jul 2025

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At a glance

  • Drugs FS-118 (Primary) ; Paclitaxel (Primary)
  • Indications Carcinoma; Haematological malignancies; Head and neck cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Sponsors F-star; F-star Therapeutics; invoX Pharma

Most Recent Events

  • 07 Aug 2024 Status changed from active, no longer recruiting to discontinued.
  • 13 Jul 2023 Paclitaxel has been added as a primary drug to the treatment regimen, patient enrollment is increased. "Expansion cohort (FS118 + paclitaxel): Incidence of Treatment Emergent Adverse Events" is added as one more primary end-point. Invox pharma has replaced F-star Therapeutics as the sponsor of this study, France is added to locations thus making it a multinational study.
  • 13 Jul 2023 Planned number of patients changed from 80 to 95.

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