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

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telix International Pty Ltd

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.