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EPITOME-1015-I: a Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of a Third Generation TCR-T Therapy, MDG1015, in Epithelial Ovarian Carcinoma, Gastroesophageal (Junction) Adenocarcinoma, Myxoid (Round Cell) Liposarcoma And/or Synovial Sarcoma Subjects with Advanced Disease Expressing NY-ESO-1 And/or LAGE-1a

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Trial Profile

EPITOME-1015-I: a Phase I Study to Investigate the Safety, Tolerability and Preliminary Efficacy of a Third Generation TCR-T Therapy, MDG1015, in Epithelial Ovarian Carcinoma, Gastroesophageal (Junction) Adenocarcinoma, Myxoid (Round Cell) Liposarcoma And/or Synovial Sarcoma Subjects with Advanced Disease Expressing NY-ESO-1 And/or LAGE-1a

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 31 Dec 2024

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At a glance

  • Drugs MDG-1015 (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Adenocarcinoma; Carcinoma; Fallopian tube cancer; Gastric cancer; Liposarcoma; Myxoid liposarcoma; Oesophageal cancer; Ovarian cancer; Solid tumours; Synovial sarcoma
  • Focus Adverse reactions; First in man
  • Acronyms EPITOME1015-I
  • Sponsors MediGene AG

Most Recent Events

  • 30 Dec 2024 Status changed from planning to not yet recruiting.
  • 16 Dec 2024 According to a MediGene AG media release, Company announced the submission of its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for its MDG1015 program for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma in the phase 1 clinical trial EPITOME1015-I.
  • 26 Nov 2024 According to a MediGene AG media release, Company will temporarily delay the start of its IND approved, clinic-ready MDG1015 Phase 1 clinical trial while actively seeking partnerships and additional financing options to advance this program into the clinic.

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