Metastatic Prostate CancerEarly Phase 1CUPIDNCT04726033
64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study)
A Early Phase 1 study testing 64Cu-DOTA-TLX592 in people with Metastatic Prostate Cancer, run by Telix Pharmaceuticals (Innovations) Pty Limited at 2 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- 64Cu-DOTA-TLX592
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesAustralia
- Study dates
- 4 Aug 2021to 29 Jan 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Envision Medical Imaging
Perth, Western Australia, 6014
GenesisCare Wembly
Perth, Western Australia, 6014
About this study
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
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.
Read the 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 the optimal dose and imaging conditions, an additional cohort of patients with a higher tumour burden such as multiple metastatic sites across ≥10 regions will be assessed.
Study conduct:
Nine, prostate cancer patients with oligometastatic disease as detected using 68Ga-PSMA-11 or 18F-DCFPyl PSMA PET/CT scanning (defined as 5 sites or less outside of the prostate bed) will be randomised to one of three treatment groups to receive a single injection of:
- Group 1: 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu.
- Group 2: 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 8mg of unlabelled TLX592 (mass dose of 10mg).
- Group 3: 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 18mg of unlabelled TLX592 (mass dose of 20mg). If one of the three patients in a specific group experiences a dose-limiting toxicity, three more patients will be treated at the same dose level.
Patients with a higher tumour burden such as multiple metastatic sites across ≥10 regions [regions: prostate bed, pelvic lumph nodes, skeleton, distant sites (including viscera)] as detected on 68Ga-PSMA or 18F-DCFPyl PMSA imaging agent will be allocated to a fourth group.
- Group 4: 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/CTscan).
For dosimetry analysis, biodistribution whole body PET/CT imaging will be performed at 1, 4 ± 0.5h, 20 ± 4h, with the option for a an additional two scans to be performed between the 36-120 hours post administration of the investigational product. The additional scans after the 20h timepoint will be at the discretion of the investigator. Patients will be imaged on a Siemens Biographe scanner, offering the possibility of TOF (time-of-flight) and non-TOF reconstruction.
Comparative tumour PET/CT imaging:
On Days 0, 1 and potentially at 36-120h the biodistribution and tumour imaging 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.
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). All image data analyses will be performed / confirmed centrally.
Pharmacokinetic analysis:
Blood samples will be taken at the following times and counted in a gamma counter:
- Pre-dose
- 1, 4 ± 0.5h, 20 ± 4h and 48 ± 4h after the administration of 64Cu-TLX592.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- 64Cu-DOTA-TLX592
- Keywords
- prostate cancer, biodistribution, 64Cu-TLX592, pharmacokinetics, dosimetery, safety
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-DOTA-TLX592Drug
Also called 64Cu-TLX592
TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592)
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 of 64Cu-TLX592 | Experimental | Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu Receives: Drug: 64Cu-DOTA-TLX592 |
| Dose level 2 of 64Cu-TLX592 | Experimental | 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). Receives: Drug: 64Cu-DOTA-TLX592 |
| Dose level 3 of 64Cu-TLX592 | Experimental | 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). Receives: Drug: 64Cu-DOTA-TLX592 |
| Confirmation of optimal 64Cu-TLX592 dose | Experimental | 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. Receives: Drug: 64Cu-DOTA-TLX592 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
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
Measured: Day 1 to 28
Pharmacokinetics 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.
Measured: Day 1-4 after a single administration of 64Cu-TLX592
Biodistribution 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)
Measured: Up to 24h after a single administration of 64Cu-TLX592
Dosimetry 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.
Measured: Up to 5 days after a single administration of 64Cu-TLX592
Secondary outcomes (2)
Optimal antibody dose of TLX592
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.
Measured: Single diagnostic administration 1 day, followed by a diagnostic scan on Day 1
Comparison of PSMA-targeting of different PMSA-imaging agents
To evaluate the comparability of PET images and PSMA-targeting characteristics between 64Cu-TLX592 and 68Ga-PSMA-11 and 18F-DCFPyl PSMA imaging agents.
Measured: Single diagnostic administration 1 day, followed by a diagnostic scan on Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start4 Aug 2021
- Primary completion30 Dec 2023
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726033
- Sponsor's protocol ID
- 64Cu-TLX592-001
- Acronym
- CUPID
- Status last verified
- Apr 2024
- First submitted
- 14 Oct 2020
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04726033
- Acronym / sponsor ID
- CUPID / 64Cu-TLX592-001
- Conditions
- Metastatic Prostate Cancer
- Keywords
- prostate cancer, biodistribution, 64Cu-TLX592, pharmacokinetics, dosimetery, safety
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Telix Pharmaceuticals (Innovations) Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 the optimal dose and imaging conditions, an additional cohort of patients with a higher tumour burden such as multiple metastatic sites across ≥10 regions will be assessed.
Study conduct:
Nine, prostate cancer patients with oligometastatic disease as detected using 68Ga-PSMA-11 or 18F-DCFPyl PSMA PET/CT scanning (defined as 5 sites or less outside of the prostate bed) will be randomised to one of three treatment groups to receive a single injection of:
- Group 1: 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu.
- Group 2: 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 8mg of unlabelled TLX592 (mass dose of 10mg).
- Group 3: 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu combined with 18mg of unlabelled TLX592 (mass dose of 20mg). If one of the three patients in a specific group experiences a dose-limiting toxicity, three more patients will be treated at the same dose level.
Patients with a higher tumour burden such as multiple metastatic sites across ≥10 regions [regions: prostate bed, pelvic lumph nodes, skeleton, distant sites (including viscera)] as detected on 68Ga-PSMA or 18F-DCFPyl PMSA imaging agent will be allocated to a fourth group.
- Group 4: 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/CTscan).
For dosimetry analysis, biodistribution whole body PET/CT imaging will be performed at 1, 4 ± 0.5h, 20 ± 4h, with the option for a an additional two scans to be performed between the 36-120 hours post administration of the investigational product. The additional scans after the 20h timepoint will be at the discretion of the investigator. Patients will be imaged on a Siemens Biographe scanner, offering the possibility of TOF (time-of-flight) and non-TOF reconstruction.
Comparative tumour PET/CT imaging:
On Days 0, 1 and potentially at 36-120h the biodistribution and tumour imaging 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.
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). All image data analyses will be performed / confirmed centrally.
Pharmacokinetic analysis:
Blood samples will be taken at the following times and counted in a gamma counter:
- Pre-dose
- 1, 4 ± 0.5h, 20 ± 4h and 48 ± 4h after the administration of 64Cu-TLX592.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 of 64Cu-TLX592 | Experimental | Drug: 64Cu-DOTA-TLX592Three patients will be intravenously administered with a single injection of 2mg of TLX592, labelled with 300 MBq (± 10%) 64Cu |
| Dose level 2 of 64Cu-TLX592 | Experimental | Drug: 64Cu-DOTA-TLX592Three 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). |
| Dose level 3 of 64Cu-TLX592 | Experimental | Drug: 64Cu-DOTA-TLX592Three 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). |
| Confirmation of optimal 64Cu-TLX592 dose | Experimental | Drug: 64Cu-DOTA-TLX592Based 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 64Cu-DOTA-TLX592Also: 64Cu-TLX592TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592) | Drug | Confirmation of optimal 64Cu-TLX592 dose, Dose level 1 of 64Cu-TLX592, Dose level 2 of 64Cu-TLX592, Dose level 3 of 64Cu-TLX592 |
Primary outcome
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
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.
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)
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.
2 secondary outcomes
Optimal antibody dose of TLX592
Time frame: Single diagnostic administration 1 day, followed by a diagnostic scan on Day 1
Comparison of PSMA-targeting of different PMSA-imaging agents
Time frame: Single diagnostic administration 1 day, followed by a diagnostic scan on Day 1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
Related trials for Metastatic Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 64Cu-DOTA-TLX592 in people with Metastatic Prostate Cancer, run by Telix Pharmaceuticals (Innovations) Pty Limited at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 (time frame: Day 1 to 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.