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A Phase I Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) With Dose Expansion Cohorts in Patients With Advanced Solid Tumors

Trial Profile

A Phase I Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) With Dose Expansion Cohorts in Patients With Advanced Solid Tumors

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 06 Jan 2026

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At a glance

  • Drugs DFP 13318 (Primary) ; Tuvusertib (Primary)
  • Indications Solid tumours; Triple negative breast cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms POP-ART

Most Recent Events

  • 02 Jan 2026 Status changed from recruiting to discontinued. (Although no safety signal has been observed, given that the industrial development of tuvusertib has been halted regardless of the results, we see no scientific and ethical justification for continuing the study)
  • 03 Mar 2025 Planned primary completion date changed from 23 Sep 2027 to 23 Sep 2028.
  • 10 Feb 2025 Planned End Date changed from 15 Feb 2029 to 23 Sep 2029.

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