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Lutetium (177Lu) DGUL Combined With Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fields
  2. Recruitment opened Start date changed from estimate of Dec 2025 to Jul 29, 2026 · Eligibility criteria expanded, about 33 words · Secondary endpoints: details revised at 13 of 22 entries · 1 more Show 4 more changesShow less
    • Start date changed from estimate of Dec 2025 to Jul 29, 2026
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 13 of 22 entries
    • Collaborators: details revised at 1 of 1 entry
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to evaluate the safety of the combination therapy of Lutetium (177Lu) DGUL and pembrolizumab. It will also assess the antitumor efficacy and pharmacokinetics of the combination therapy compared to Lutetium (177Lu) DGUL monotherapy. Participants will: Monotherapy: Receive Lutetium (177Lu) DGUL 4 times (plus 2 additional doses) at 6-week intervals Combination therapy: Receive Lutetium (177Lu) DGUL 4 times (plus 2 additional doses) at 6-week intervals along with pembrolizumab up to 18 times at 6-week intervals
Trial Details
NCT Number NCT07244393
Lead Sponsor Cellbion Co., Ltd.
Collaborators: Merck Sharp & Dohme LLC
Conditions Metastatic Castration-resistant Prostate Cancer (mCRPC)
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov