Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer (CRPC)

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Apr 20, 2027 → Aug 2027
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Record History

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  1. Primary completion pushed from Apr 20, 2027 to Aug 2027 Show 5 more changesShow less
    • Study completion pushed from Apr 20, 2027 to Oct 2031
    • Interventions: 45 kBq/kg Ac-225 rosopatamab tetraxetan (Biological), 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan… to 45 kBq/kg Ac-225 rosopatamab tetraxetan (Biological), 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan…
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 1 of 9 entries
    • Site details revised at 4 of 9 sites
  2. Enrollment target: 60 to 93v12 Show 7 more changesShow less
    • Primary completion date: Dec 2025 to Apr 20, 2027
    • Primary endpoints: 6 to 8
    • Study completion date: Apr 2027 to Apr 20, 2027
    • Interventions: 45 kBq/kg Ac-225 rosopatamab tetraxetan (Biological), 55 kBq/kg Ac-225 rosopatamab tetraxetan (Biological), 60 kBq/kg Ac-225 rosopatamab… to 45 kBq/kg Ac-225 rosopatamab tetraxetan (Biological), 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan…
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 7 to 9
    • Study arms: 4 to 5
  3. Study sites: 8 to 9v11
  4. Study sites: 7 to 8v10
  5. Eligibility criteria expanded, about 37 wordsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Enrollment target: 47 to 60
    • Study sites: 5 to 7
    v8
  2. Site contacts updated at 1 of 5 sitesv7
  3. Study sites: 4 to 5v6
  4. Site contacts updated at 1 of 4 sitesv5
  5. Study sites: 2 to 4v4 Show 4 more changesShow less
    • Interventions: 45 KBq/kg Ac-225 rosopatamab tetraxetan (Biological), 55 KBq/kg Ac-225 rosopatamab tetraxetan (Biological), 60 KBq/kg Ac-225 rosopatamab… to 45 kBq/kg Ac-225 rosopatamab tetraxetan (Biological), 55 kBq/kg Ac-225 rosopatamab tetraxetan (Biological), 60 kBq/kg Ac-225 rosopatamab…
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Study title expanded, about 1 word
  6. Study sites: 1 to 2
    • Start date changed from estimate of Aug 2024 to Aug 6, 2024
    v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • 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 is a four-part study evaluating the safety and efficacy of a PSMA-directed radioantibody (rosopatamab tetraxetan, conjugated to either In-111 or Ac-225). Part 1 will consist of one administration of In-111-rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants then will be enrolled into either Part 2 (Dose Optimization) or Part 3 (Dose Escalation and Expansion) depending on their prior treatment history. Part 4 will be an extended regimen in dose escalation and expansion. Participants qualifying for Part 2 will be randomized to receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle (dose administration on Day 1 and Day 15) at either 45 or 60 kBq/Kg. Participants qualifying for Part 3 must have received prior Lu-177-PSMA-radioligand therapy and will receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle at 45, 55, or 60 kBq/Kg. Dose limiting toxicities (DLTs) will be monitored in Part 3 to determine the recommended phase 2 dose (RP2D), and the study may enroll additional participants to be treated with the RP2D dose level. Participants qualifying for Part 4 will initially receive two doses (dose administration on Day 1 and Day 15) at the dose level selected in Part 2, followed by a single third dose of Ac-225 rosopatamab tetraxetan administered approximately 12 weeks after completion of the Part 2 fractionated dosing regimen. The starting dose level for Part 4 will be 22 kBq/kg (or fixed activity equivalent). Dose limiting toxicities (DLTs) will be monitored following administration of the third dose in Part 4 to determine the recommended phase 2 dose (RP2D) of a third dose of Ac-225 rosopatamab tetraxetan. Participants enrolled into any part will attend study visits which will include blood samples, electrocardiogram (ECG), radiographic imaging, and physical examinations along with other assessments.
Trial Details
NCT Number NCT06549465
Lead Sponsor Convergent Therapeutics
Conditions
(from sponsor)		 PSMA PET-Positive Castration-Resistant Prostate Cancer
Enrollment 93 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov