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A Phase 1 Trial to Investigate the Safety, Pharmacokinetic Profiles and the Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies

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Trial Profile

A Phase 1 Trial to Investigate the Safety, Pharmacokinetic Profiles and the Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 29 Jul 2024

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At a glance

  • Drugs Tinostamustine (Primary)
  • Indications Carcinoma; Cutaneous T-cell lymphoma; Diffuse large B cell lymphoma; Fallopian tube cancer; Haematological malignancies; Hodgkin's disease; Multiple myeloma; Mycosis fungoides; Non-Hodgkin's lymphoma; Ovarian cancer; Peripheral T-cell lymphoma; Peritoneal cancer; Sezary syndrome; Small cell lung cancer; Soft tissue sarcoma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Mundipharma GmbH

Most Recent Events

  • 25 Jul 2024 Study arms increased from 1 to 15.
  • 25 Jul 2024 Status changed from active, no longer recruiting to completed.
  • 12 Dec 2023 Results (n=48) assessing safety and efficacy findings for tinostamustine in an expansion cohort of patients with CTCL in patients with advanced haematological malignancies presented at the 65th American Society of Hematology Annual Meeting and Exposition

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