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A Phase 1 Study of RGX-202-01 (Ompenaclid) , a Small Molecule Inhibitor of the Creatine Transporter SLC6a8, as a Single Agent and as Combination Therapy in Patients With Advanced Gastrointestinal Malignancies With Select Expansion Cohorts

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A Phase 1 Study of RGX-202-01 (Ompenaclid) , a Small Molecule Inhibitor of the Creatine Transporter SLC6a8, as a Single Agent and as Combination Therapy in Patients With Advanced Gastrointestinal Malignancies With Select Expansion Cohorts

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 30 Oct 2024

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At a glance

  • Drugs Bevacizumab (Primary) ; Fluorouracil (Primary) ; Folinic acid (Primary) ; Irinotecan (Primary) ; Ompenaclid (Primary)
  • Indications Adenocarcinoma; Biliary cancer; Colorectal cancer; Gastric cancer; Gastrointestinal cancer; Intestinal cancer; Oesophageal cancer; Pancreatic cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Inspirna

    • Most Recent Events

    • 13 May 2024 Planned number of patients changed from 60 to 108.
    • 13 May 2024 Number of treatment arms are increased from 3 to 5 by the addition of 1 Dose Escalation and 1 Dose Expansion arm for Ompenaclid (RGX-202-01) in combination with FOLFOX. In this arm, patients with previously untreated metastatic colorectal adenocarcinoma are enrolled, adding it to the indications.
    • 13 May 2024 Planned primary completion date changed from 31 Dec 2023 to 31 Dec 2024.

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