advanced tumours Metastatic tumours
Conditions
Interventions
Radio-labeled CB307
Sponsors
Cresendo Biologics Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •To assess the safety of 89Zr-CB307: Incidence (frequency and severity) of adverse events occurring following administration of 89Zr-CB307 assessed by CTCAE ver 5.0; •To assess 89Zr-CB307 uptake by PET scan: SUVpeak - maximum standardised uptake value; SUVmean - mean standardised uptake value; Percentage of Injected Dose per Gram of Tissue (%ID/g) in the tumour. | — |
Secondary
| Measure | Time frame |
|---|---|
| During the conduct of the sub-study, multiple PET scans will be performed and safety assessments for the evaluation of the safety profile will be done. In addition, safety laboratory parameters and electrocardiogram (ECG) data will be evaluated using data after completion of the sub-study and prior to commencing C1D1 of the main study. Any AEs or SAEs that occur during the screening period or the sub-study will be followed up until resolution. If the AE is not resolved at the time of completion of the sub-study or by the required follow-up period of the sub-study, these data will be reported in the main study. | — |
Countries
Netherlands
Outcome results
None listed