Ac-225 rosopatamab tetraxetan (CONV01-α) / Dominari Holdings 
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  • ||||||||||  Ac-225 rosopatamab tetraxetan (CONV01-?) / Dominari Holdings
    Enrollment closed, Enrollment change:  Re-treatment 225Ac-J591 for mCRPC (clinicaltrials.gov) -  Sep 25, 2024   
    P1,  N=6, Active, not recruiting, 
    Suspended --> Recruiting Recruiting --> Active, not recruiting | N=18 --> 6
  • ||||||||||  Ac-225 rosopatamab tetraxetan (CONV01-?) / Dominari Holdings
    Trial suspension, Metastases:  Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC (clinicaltrials.gov) -  Jul 30, 2024   
    P1/2,  N=105, Suspended, 
    Recruiting --> Suspended | Trial primary completion date: Jun 2025 --> Jun 2026 Recruiting --> Suspended
  • ||||||||||  Ac-225 rosopatamab tetraxetan (CONV01-?) / Dominari Holdings
    Trial completion, Trial completion date, Metastases:  7R01CA207645-03: Phase I Trial of 225Ac-J591 in Patients With mCRPC (clinicaltrials.gov) -  Nov 2, 2023   
    P1,  N=32, Completed, 
    Genomic alterations in DRR proteins did not have clear implications. Active, not recruiting --> Completed | Trial completion date: Jul 2024 --> Sep 2023
  • ||||||||||  Ac-225 rosopatamab tetraxetan (CONV01-?) / Dominari Holdings
    Trial completion date, Trial primary completion date:  Re-treatment 225Ac-J591 for mCRPC (clinicaltrials.gov) -  Oct 31, 2023   
    P1,  N=18, Recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Jul 2024 --> Sep 2023 Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2025
  • ||||||||||  Ac-225 rosopatamab tetraxetan (CONV01-?) / Dominari Holdings
    Enrollment change, Trial initiation date, Trial withdrawal, Metastases:  ACTION: ACTInium-J591 Radionuclide Therapy in PSMA-Detected Metastatic HOrmone-Sensitive Recurrent Prostate CaNcer (clinicaltrials.gov) -  Aug 24, 2023   
    P1,  N=0, Withdrawn, 
    NLR provides prognostic information in the setting of patients with mCRPC receiving treatment with PSMA-TRT. N=24 --> 0 | Initiation date: Jun 2023 --> Dec 2023 | Not yet recruiting --> Withdrawn
  • ||||||||||  rosopatamab-225Ac (CONV01-?) / Weill Cornell Medical College, Dominari Holdings
    PSMA-alpha targeted radionuclide therapy (TRT) with or without prior PSMA-beta TRT () -  Jul 27, 2023 - Abstract #ESMO2023ESMO_3282;    
    Here, we evaluate baseline demographics and prior exposures for association with outcome following treatment with 225Ac-J591...Risk of Gr 4 plts appears highest in those with prior 177Lu and Ra223 and EBRT, but high-grade events are rare. New examination of organ dose-limits with TRT is warranted.
  • ||||||||||  rosopatamab-225Ac (CONV01-?) / Weill Cornell Medical College, Dominari Holdings
    Phase I dose-escalation study of fractionated dose 225Ac J591 for metastatic castration resistant prostate cancer (W Hall A2-3 - Convention Center) -  Mar 14, 2023 - Abstract #AACR2023AACR_4404;    
    Background: PSMA-based targeted radionuclide therapy is now a standard of care for mCRPC since approval of 177Lu-PSMA-617. A single fractionated cycle of 225Ac-J591 was delivered with few high grade AEs and with evidence of preliminary efficacy by PSA and CTC changes across all dose levels.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), rosopatamab-225Ac (CONV01-?) / Weill Cornell Medical College, AIkido Pharma
    Phase I results of a phase I/II study of pembrolizumab and AR signaling inhibitor (ARSI) with 225Ac-J591. (On Demand | Level 1, West Hall; Poster Board No. F18) -  Jan 10, 2023 - Abstract #ASCOGU2023ASCO_GU_305;    
    P1/2
    A key safety signal that has emerged with triplet therapy is CRS that can be managed supportively. The randomized phase II component is accruing with additional safety visits and sample collection for cytokine analysis.
  • ||||||||||  Pluvicto (lutetium Lu 177 vipivotide tetraxetan) / Novartis, rosopatamab-225Ac (CONV01-α) / Weill Cornell Medical College, AIkido Pharma
    Circulating tumor DNA (ctDNA) and prognosis with PSMA-targeted radionuclide therapy (TRT) (Poster Area, Hall 4) -  Jul 28, 2022 - Abstract #ESMO2022ESMO_3026;    
    P1, P1/2
    Similar results as this combined study were obtained when individual studies of 177Lu-PSMA-617 or 225Ac-J591 were analyzed for AR copy number and asP. Conclusions ctDNA analysis, a non-invasive technique, in patients undergoing PSMA-TRT demonstrate that AR copy number gain and high allele-specific ploidy, reflecting genomic instability and complex karyotype, are associated with poorer prognosis.
  • ||||||||||  rosopatamab-225Ac (CONV01-α) / Weill Cornell Medical College, AIkido Pharma
    CTC-based biomarker analysis and correlation with clinical response to PSMA-TRT in mCRPC (Section 31) -  Mar 9, 2022 - Abstract #AACR2022AACR_3181;    
    P1
    To investigate the role of PSMA expression and CRT membrane localization as a biomarker of response to PSMA-TRT, we isolated circulating tumor cells (CTCs) from patients with mCRPC, enrolled in a phase I dose escalation trial of 225Ac-J591 (NCT03276572)...Our preliminary results indicate higher expression of plasma membranous CRT in on-treatment CTCs in responders (PFS>12 months; n= 39 CTCs from 3 patients) than in non-responders (PFS<3 months; n= 20 CTCs from 2 patients). Full analysis of CRT and PSMA expression is currently being completed.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), rosopatamab-225Ac (CONV 01-α) / Weill Cornell Medical College, AIkido Pharma
    Phase I/II trial of pembrolizumab and AR signaling inhibitor +/- 225Ac-J591 for chemo-naive metastatic castration-resistant prostate cancer (mCRPC). (In-Person & On Demand | Level 1, West Hall - R2) -  Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_236;    
    P1/2
    Exploratory objectives include assessment of immunogenic cell death, immune serologic and host microbiome changes, plasma ctDNA, serial PSMA PET, and patient reported outcomes (FACT-P, BPI, EQ-5D-5L). The phase I portion of this DOD-funded study was activated in summer 2021 with the randomized phase II portion expected to open at PCCTC sites in 2022.