A Phase I Study to Assess Biodistribution of 89Zr-CB307 in PSMA+ and PSMA-Tumour Lesions

Completed

Conditions: advanced tumours
Metastatic tumours
10027655

Registration Number: NL-OMON51775

Lead Sponsor: Cresendo Biologics Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1. Is capable of understanding the written informed consent form (ICF),
provides signed and witness informed consent and agrees to comply with protocol
requirements
2. Is aged at least 18 years at the time of signing the ICF
3. Has a documented, histologically-confirmed diagnosis of advanced or
metastatic solid tumours

See protocol page 26 for the full list of inclusion criteria)
Note: Subject must qualify for the main study and must have met the relevant
inclusion and exclusion criteria and signed the ICF for the main study (see
also section J)

Exclusion Criteria

1. Has evidence of autoimmune or significant, uncontrolled concomitant diseases
that could affect compliance with the protocol or interpretation of the results
2. Has discontinued from anti-cytotoxic lymphocyte-associated protein 4,
anti-programmed cell death protein 1, or anti-programmed cell death ligand 1
antibody because of intolerable toxicity according to the investigator*s
assessment.
3. Has brain metastasis, including leptomeningeal metastasis or a primary brain
tumour.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>•To assess the safety of 89Zr-CB307: Incidence (frequency and severity) of<br /><br>adverse events occurring following administration of 89Zr-CB307 assessed by<br /><br>CTCAE ver 5.0;<br /><br>•To assess 89Zr-CB307 uptake by PET scan: SUVpeak - maximum standardised uptake<br /><br>value; SUVmean - mean standardised uptake value; Percentage of Injected Dose<br /><br>per Gram of Tissue (%ID/g) in the tumour.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>During the conduct of the sub-study, multiple PET scans will be performed and<br /><br>safety assessments for the evaluation of the safety profile will be done. In<br /><br>addition, safety laboratory parameters and electrocardiogram (ECG) data will be<br /><br>evaluated using data after completion of the sub-study and prior to commencing<br /><br>C1D1 of the main study. Any AEs or SAEs that occur during the screening period<br /><br>or the sub-study will be followed up until resolution. If the AE is not<br /><br>resolved at the time of completion of the sub-study or by the required<br /><br>follow-up period of the sub-study, these data will be reported in the main<br /><br>study.</p><br>