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64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study) (CUPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04726033
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : August 13, 2021
Sponsor:
Information provided by (Responsible Party):
Telix International Pty Ltd

Brief Summary:
This is a Phase 1 trial of TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592). TLX592 is being developed as a PSMA-targeting antibody to be radiolabelled with a therapeutic radiosotope for the treatment of PSMA-expressing tumours, therefore this study has been designed to assess the safety and tolerability, pharmacokinetics, whole body biodistribution and radiation dosimetry of 64Cu-TLX592.

Condition or disease Intervention/treatment Phase
Metastatic Prostate Cancer Drug: 64Cu-DOTA-TLX592 Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will consist of four groups with the initial three groups undergoing dose escalation and the fourth group will be to confirm the optimal dose and imaging conditions.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Single Centre, Open-label Study of TLX592 to Assess the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry in Patients Diagnosed With Prostate Cancer
Actual Study Start Date : August 4, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Dose level 1 of 64Cu-TLX592
Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu
Drug: 64Cu-DOTA-TLX592
TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592)
Other Name: 64Cu-TLX592

Experimental: Dose level 2 of 64Cu-TLX592
Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 8mg of unlabelled TLX592 (mass dose of 10mg).
Drug: 64Cu-DOTA-TLX592
TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592)
Other Name: 64Cu-TLX592

Experimental: Dose level 3 of 64Cu-TLX592
Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 18mg of unlabelled TLX592 (mass dose of 20mg).
Drug: 64Cu-DOTA-TLX592
TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592)
Other Name: 64Cu-TLX592

Experimental: Confirmation of optimal 64Cu-TLX592 dose

Based on the result of Groups 1-3, the optimal dose and imaging timepoints will be selected to treat 3 patients with higher tumour burden (≥10 metastatic sites and/or visceral disease as detected on a 68Ga-PSMA-11 or 18F-DCFPyl PSMA PET/CT scan).

Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 0, 8 or 18mg of unlabelled TLX592.

Drug: 64Cu-DOTA-TLX592
TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592)
Other Name: 64Cu-TLX592




Primary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [ Time Frame: Day 1 to 28 ]
    Treatment emergent adverse events (TEAE) will be classified according to MedDRA (Medical Dictionary for Regulatory Activities), frequency, severity according to NCI CTCAE V5.0, seriousness, and relationship of study treatment will be assessed. Laboratory abnormalities will be assessed according to the NCI CTCAE v.5.0

  2. Pharmacokinetics of 64Cu-TLX592 [ Time Frame: Day 1-4 after a single administration of 64Cu-TLX592 ]
    Patient plasma samples at 0h, 1h, 4 ± 0.5h, 20 ± 4h and 48 ± 4h after the administration of 64Cu-TLX592 will be counted for radioactivity.

  3. Biodistribution of 64Cu-TLX592 [ Time Frame: Up to 24h after a single administration of 64Cu-TLX592 ]
    On Days 0, Day 1 and potentially at 36-120h after administration of the investigational product, the biodistribution and tumour imaging will be performed. An end of study visit will be conducted on Day 28 ± 2 days. 64Cu-TLX592 images will be centrally analysed for absorbed organ and whole body doses in a standardised fashion. In addition, tumour absorbed doses will be determined for scientific purposes (estimation of achievable tumour doses of therapeutic nuclides labelled to TLX592)

  4. Dosimetry of 64Cu-TLX592 [ Time Frame: Up to 5 days after a single administration of 64Cu-TLX592 ]
    For dosimetry analysis, biodistribution whole body PET/CT imaging will be performed at 1h, 4 ± 0.5h, 20 ± 4h, with the option for a an additional two scans to be performed between the 36-120 hours.


Secondary Outcome Measures :
  1. Optimal antibody dose of TLX592 [ Time Frame: Single diagnostic administration 1 day, followed by a diagnostic scan on Day 1 ]
    The optimal antibody mass dose and its effect on the biological clearance of 64Cu- TLX592 from blood and radiation dose to tumour will be conducted on Day 0, Day 1 and potentially at 36-120h. The optimal antibody mass dose will be performed using gated or list mode acquisition, for generation of sub-partitioned data. Such data will allow the mathematical generation of statistically independent images for various dose levels, based on the actual dose administered in the trial.

  2. Comparison of PSMA-targeting of different PMSA-imaging agents [ Time Frame: Single diagnostic administration 1 day, followed by a diagnostic scan on Day 1. ]
    To evaluate the comparability of PET images and PSMA-targeting characteristics between 64Cu-TLX592 and 68Ga-PSMA-11 and 18F-DCFPyl PSMA imaging agents.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent.
  • Biochemically recurrent metastatic adenocarcinoma of the prostate, or metastatic primary adenocarcinoma of the prostate.
  • Histologically or cytologically confirmed diagnosis of adenocarcinoma of prostate.
  • PSMA-expressing prostate adenocarcinoma as seen on 68Ga-PSMA-11 or 18F- DCFPyl PSMA PET/CT scanning within the last 1 month showing PSMA-avid disease.
  • ECOG performance status of 0 - 1.
  • Normal organ function and marrow reserve:
  • White blood cell (WBC) count ≥ 2.5 x 109/L or absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
  • Platelets ≥ 100 x 109/L.
  • Haemoglobin ≥ 90g/L.
  • Bilirubin < 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5 - 2x ULN, must have a normal conjugated bilirubin).
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.0 x ULN (or

    • 5.0 x ULN in the presence of liver metastases).
  • Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min.

Exclusion Criteria:

A patient is excluded from participation in the trial if one or more of the following criteria are met:

  • Known active brain metastases.
  • Serious active infection (as assessed by investigator).
  • Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or haematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
  • Known or suspected allergies, hypersensitivity, or intolerance to the IMP or its excipients.
  • Other investigational agents within 4 weeks of randomization.
  • Radiotherapy or immunotherapy within 4 weeks prior to the planned administration of 64Cu-TLX592 or continuing adverse effects (> grade 1) from such therapy [Common Terminology Criteria for Adverse Events (CTCAE) version 5].
  • Previous administration of any radionucleotide within 10 half-lives of 64Cu.
  • Inability to understand, or unwilling to sign, a written informed consent document or to follow investigational procedures in the opinion of the investigator.
  • Patients who are unable to maintain self-care.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726033


Contacts
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Contact: Nat Lenzo, MD +61 02 8236 3300 Nat.Lenzo@genesiscare.com
Contact: Tracey Brown, PhD 0412010104 tracey.brown@telixpharma.com

Locations
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Australia, Western Australia
Envision Medical Imaging Recruiting
Perth, Western Australia, Australia, 6014
Contact: Nat Lenzo, MD         
GenesisCare Wembly Recruiting
Perth, Western Australia, Australia, 6014
Contact: Nat Lenzo, MD,PhD         
Sponsors and Collaborators
Telix International Pty Ltd
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Responsible Party: Telix International Pty Ltd
ClinicalTrials.gov Identifier: NCT04726033    
Other Study ID Numbers: 64Cu-TLX592-001
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Telix International Pty Ltd:
prostate cancer
biodistribution
64Cu-TLX592
pharmacokinetics
dosimetery
safety
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases