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A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard Therapy

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 11, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Enrollment target: estimated 73 to confirmed 91v8
  2. Minor Trial status: Recruiting to Active, Not Recruiting Site details revised at 4 of 4 sitesv7 Show 1 more changeShow less
    • Site details revised at 4 of 4 sites
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Minor Secondary endpoints: details revised at 5 of 14 entriesv5
  5. Minor Study sites: 1 to 4v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Primary completion date: Aug 31, 2023 to Dec 31, 2024 Completion date: Dec 31, 2023 to Dec 31, 2024v3 Show 1 more changeShow less
    • Completion date: Dec 31, 2023 to Dec 31, 2024
  2. Minor Eligibility criteria shortened, about 1 wordv2 See this version in full on ClinicalTrials.gov ↗
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This clinical trial is an open-label, single-arm, multi-center, escalation (Phase 1 Part B only), rater-blind (Phase 2 only), phase 1/2 trial to evaluate the diagnostic validity/safety of Ga-68-NGUL and efficacy/safety of Lu-177-DGUL on the anti-tumor activity that aims to simultaneously evaluate diagnostic and therapeutic validity.
Trial Details
NCT Number NCT05547061
Lead Sponsor Cellbion Co., Ltd.
Conditions Prostate Cancer, mCRPC
Enrollment 91 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov