Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Clarity Pharmaceuticals Ltd|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Neuroblastoma, Relapsed Neuroblastoma, Refractory Neuroblastoma|
This is an 'adaptive trial'. The trial design uses the accumulating data from the ongoing trial to modify aspects of the trial (e.g. dose, number of treatments). The trial is also a 'personalised trial' as the interval between treatments and number of treatments is determined for each patient individually. This study is to be conducted in 2 phases, a dose escalation phase and a cohort expansion phase. Dose escalation will be completed using a modified 3+3 study design with up to 4 Cohorts of increasing doses in MBq/kg. Pre-defined Dose Limiting Toxicities will be monitored for 6 weeks post administration of 1 therapy cycle of 67Cu-SARTATE. Participants who demonstrate therapeutic benefit (defined as non progression as assessed by the Investigator using the International Neuroblastoma Response Criteria (INRC) guidelines) may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total). Cohort expansion will commence once either the Maximum Tolerated Dose (MTD) for a single administration of 67Cu-SARTATE is established, or Cohort 4 has been completed. The study will be expanded to enroll an additional 10 subjects who will receive at least 2 therapy cycles of 67Cu-SARTATE at the MTD dose level. Participants who demonstrate therapeutic benefit (defined as non progression as assessed by the Investigator using the INRC guidelines) may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total). The study also includes a long-term follow-up period to 36 months following the first dose of 67Cu-SARTATE, although in person study visits are not required.
64Cu-SARTATE - patients will receive a bolus injection of 64Cu-SARTATE during screening, and following each 67Cu-SARTATE Therapy Cycle at a rate of 2.0 MBq/kg. 67Cu-SARTATE - In the dose escalation phase, patients will receive a single administration of 67Cu-SARTATE as an IV infusion (dose will be determined based on cohort allocation). In the expansion phase, patients will receive at least 2 administrations of 67Cu-SARTATE a the MTD level as a slow IV infusion. Participants in either phase of the study that demonstrate therapeutic benefit following treatment with 67Cu-SARTATE at any dose may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total).
Drug: - 67Cu-SARTATE
Drug: - 64Cu-SARTATE
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.