Early-phase clinical trial of 64Cu-PD-32766

JRCT ID: jRCTs031240046

Registered date:24/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Clear cell renal cell carcinoma
• Date of first enrollment: 24/04/2024
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Single intravenous administration of 148 MBq of 64Cu-PD-32766

Outcome(s)

• Primary Outcome: per-patient PET sensitivity
• Secondary Outcome: per-lesion PET sensitivity, safety, pharmacokinetics, estimated irradiation dose

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) proven prostate cancer.
2) The presence of any of the following lesions can be confirmed by imaging examinations (CT, MRI):
Distant metastatic lesions (including distant metastatic recurrence)
Local recurrence lesions from the site of removal after total nephrectomy of the diseased kidney
3) satisfying the following within 28 days before registration:
3)-1 hematopoietic function
neutrophil >= 1,500 /microL (G-CSF independent)
platelets >= 100,000 /microL (transfusion independent)
Hb >= 8.0 g/dL (transfusion independent)
3)-2 renal function
eGFR >= 30 mL/min/1.73m2
3)-3 hepatic function
ALT < 3 time upper limit of normal
AST < 3 time upper limit of normal
T-Bil < 1.5 time upper limit of normal
3)-4 heart function
NYHA <= 1
3)-5 respiratory function
SpO2 >= 96% (at room air)
4) ECOG PS 0 or 1 within 28 days before registration.
5) 18-year-old and more person.
6) written informed consent to participate in the current clinical trial.

Exclude criteria

1) current malignancies other than prostate cancer.
2) HBV (or carrier), HCV, HIV, or any other active infections which need to be treated during the current trial.
3) any of the following conditions / diseases of poor control.
symptomatic congestive heart failure, unstable angina, myocardial infarction, arrythmia, any valvular diseases, any aortic disorders, respiratory disorders (which need to medications or physical treatment such as oxygen administration, continuous positive pressure breathing therapy), interstitial pulmonary disorder, pleural effusion, ascites, hemorrhagic diathesis (e.g., hemophilia, idiopathic thrombocytopenic purpura, antiplatelet therapy, anticoagulant therapy), diabetes mellitus (HbA1c >=8.0%)
4) current poorly-controlled psychiatric disorder.
5) pregnant, potentially pregnant, or breastfeeding woman.
6) difficulty in complying with the instructions of the investigator in the radiation-controlled area.
7) possibility of administration of radiopharmaceuticals other than the study drug.
8) history of administration of 64Cu-PD-32766
9) any other reasons that the patient cannot participate in the current clinical trial.

Related Information

• Primary Sponsor: Inaki Anri
• Secondary Sponsor: Peptidream Inc.