Part A: A First-in-Human Single Ascending Dose Study of TRX518 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies Part B: A Dose-Escalation Study of Multi-dose TRX518 Monotherapy Part C: An Expansion Cohort of Multi-dose TRX518 Monotherapy at the Maximum Tolerated Dose

Trial Profile

Part A: A First-in-Human Single Ascending Dose Study of TRX518 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies Part B: A Dose-Escalation Study of Multi-dose TRX518 Monotherapy Part C: An Expansion Cohort of Multi-dose TRX518 Monotherapy at the Maximum Tolerated Dose

Recruiting
Phase of Trial: Phase I

Latest Information Update: 03 Apr 2017

At a glance

  • Drugs TRX 518 (Primary)
  • Indications Malignant melanoma; Solid tumours
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics
  • Acronyms TRXMel-1
  • Sponsors GITR Inc
  • Most Recent Events

    • 03 Apr 2017 Results published in a Leap Therapeutics media release.
    • 03 Apr 2017 Results from this trial were presented at the 2017 American Association for Cancer Research (AACR) Annual Meeting, according to a Leap Therapeutics media release.
    • 07 Mar 2017 Protocol amended to include An Expansion Cohort of Multi-dose TRX518 Monotherapy at the Maximum Tolerated Dose . Planned patient enrollement changed from 40 to 71.
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