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Upifitamab Rilsodotin (Xmt-1536) An Open-Label, Multicenter, Dose Escalation And Expansion Study Of Upifitamab Rilsodotin In Combination With Carboplatin In Participants With High Grade Serous Ovarian Cancer (Upgrade-A)

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Trial Profile

Upifitamab Rilsodotin (Xmt-1536) An Open-Label, Multicenter, Dose Escalation And Expansion Study Of Upifitamab Rilsodotin In Combination With Carboplatin In Participants With High Grade Serous Ovarian Cancer (Upgrade-A)

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 12 Oct 2023

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At a glance

  • Drugs Carboplatin (Primary) ; Upifitamab rilsodotin (Primary)
  • Indications Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Adverse reactions; Proof of concept
  • Acronyms UPGRADE; UPGRADE-A
  • Sponsors Mersana Therapeutics

    • Most Recent Events

    • 06 Oct 2023 Status changed from suspended to discontinued as study has been terminated by the sponsor.
    • 15 Jun 2023 According to Mersana media release, the U.S. Food and Drug Administration (FDA) has issued a partial clinical hold pausing new patient enrollment in this study. This follows a submission by the company of a recent aggregate safety report of all patients dosed with UpRi (approximately 560 patients) evaluating bleeding events. The company plans to seek alignment with the FDA to lift the partial clinical hold and resume enrollment.
    • 06 Jun 2023 The dose escalation portion of UPGRADE-A has completed enrollment, and the EXP portion is ongoing and expected to enroll 30 patients as reported in trial design presented at the 59th Annual Meeting of the American Society of Clinical Oncology
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