Status:
COMPLETED
64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study)
Lead Sponsor:
Telix Pharmaceuticals (Innovations) Pty Limited
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
Phase:
EARLY_PHASE1
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-ta...
Detailed Description
The optimisation dose and imaging conditions will be conducted in prostate cancer patients with with oligometastatic disease ( (defined as 5 sites or less outside of the prostate bed). On determining ...
Eligibility Criteria
Inclusion
- 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
- 0 x ULN in the presence of liver metastases).
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min.
Exclusion
- 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.
Key Trial Info
Start Date :
August 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04726033
Start Date
August 4 2021
End Date
January 29 2024
Last Update
May 1 2024
Active Locations (2)
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1
Envision Medical Imaging
Perth, Western Australia, Australia, 6014
2
GenesisCare Wembly
Perth, Western Australia, Australia, 6014