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A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC).

Trial Profile

A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC).

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 Nov 2024

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At a glance

  • Drugs Darolutamide (Primary) ; Gedatolisib (Primary)
  • Indications Prostate cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Celcuity

Most Recent Events

  • 14 Nov 2024 According to a Celcuity media release, trial is ongoing and expected to report preliminary data in Q2 2025.
  • 14 Aug 2024 According to a Celcuity media release,Research and development (R&D) expenses were $22.5 million for the second quarter of 2024, supporting the VIKTORIA-1 Phase 3 trial and the initiation of the CELC-G-201 Phase 1b/2 clinical trial.
  • 14 Aug 2024 According to a Celcuity media release, company remains on track to report preliminary data in the first half of 2025.Enrollment is ongoing and the trial is expected to enroll up to 54 patients with mCRPC whose disease progressed after treatment with an androgen receptor signaling inhibitor.

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