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Phase I, Two-Part, Multi-Center, First-in-Human Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

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Trial Profile

Phase I, Two-Part, Multi-Center, First-in-Human Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

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

Latest Information Update: 03 Nov 2025

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At a glance

  • Drugs Raludotatug deruxtecan (Primary)
  • Indications Ovarian cancer; Renal cell carcinoma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Daiichi Sankyo Inc

Most Recent Events

  • 15 Sep 2025 According to a Daiichi Sankyo Company media release, Raludotatug deruxtecan received Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab based on phase I and phase II/III REJOICE-Ovarian01 studies.
  • 28 Jul 2025 Planned End Date changed from 30 Nov 2025 to 30 Jun 2026.
  • 28 Jul 2025 Planned primary completion date changed from 21 Apr 2025 to 30 Apr 2026.

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