NCT04726033CompletedEarly phase 1
64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study)
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
Source: ClinicalTrials.gov · Last updated 1 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 14 Oct 2020
- Start date
- 4 Aug 2021
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT04726033
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 14
- From 4 Aug 2021 to the primary completion date, 30 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
- A patient is excluded from participation in the trial if one or more of the following criteria are met:
- Known active brain metastases.
- 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.
Who the study is looking for
- 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.
Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GenesisCare Wembly Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Envision Medical Imaging Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.