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The primary purpose of this study is to investigate the safety and tolerability of a single dose of Cu-64 SARTATE and multiple doses of Cu-67 SARTATE administered to participants with meningioma. All participants in this study will be injected with a single dose of Cu-64 SARTATE to demonstrate how it is absorbed in the body. Then participants will receive individualised doses of Cu-67 SARTATE for up to 4 cycles.
This is a single centre, open label, non-randomised, single cohort, multiple dose study of Cu-67 SARTATE administered to male and female participants diagnosed with grade I, II, or III meningioma. The maximum allowable dose will be calculated using dosimetry data acquired from PET/CT scans completed during a pre-treatment diagnostic & dosimetry phase using Cu-64 SARTATE, a structurally identical molecule radiolabelled with copper-64 (Cu-64), instead of copper-67 (Cu-67). Approximately 6 participants will be enrolled in the study. Participants will have up to 4 therapy cycles (6-12 weeks apart). Safety visits will occur between each cycle at bi-weekly intervals to ensure the participant meets the safety criteria prior to their next therapy. An efficacy assessment will be conducted following cycle 2 to determine if a subsequent 2 cycles of therapy will be administered. Participants who complete all four cycles of Cu-67 SARTATE therapy, will complete their final study visit at 12 weeks post administration of cycle 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARTATE | Experimental | All participants will receive 200 MBq of Cu-64 SARTATE given as a single bolus intravenous injection at Day 0. Participants will receive up to four administrations of Cu-67 SARTATE via a slow intravenous infusion over 30 minutes, 6 to 12 weeks apart. Individual activity administered per cycle will not exceed 5.1 GBq. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cu-64 SARTATE and Cu-67 SARTATE | Drug | Cu-64 SARTATE diagnostic drug Cu-67 SARTATE therapy drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of multiple doses of Cu-67 SARTATE using CTCAE version 4.03 | Safety will be assessed via vital signs, laboratory tests, physical examinations, ECGs and spontaneous adverse event reporting. | 55 weeks |
| Safety and tolerability of a single dose of Cu-64 SARTATE using CTCAE version 4.03 | Safety will be assessed via vital signs, laboratory tests, physical examinations, ECGs and spontaneous adverse event reporting. | 56 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absorbed dose of Cu-64 SARTATE in target, non-target organs and whole body. | Absorbed doses (mSv/MBq) will be calculated using PET/CT scans acquired at 1, 4 and 24 hours post administration of Cu-64 SARTATE. | 1, 4 and 24 hours post administration of Cu-64 SARTATE. |
| Absorbed dose of Cu-67 SARTATE in target, non-target organs and whole body. |
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Inclusion Criteria:
Signed informed consent.
Age greater than or equal to 50 years.
Life expectancy greater than or equal to 3 months.
Has adequate organ function as defined by the following laboratory values obtained within 28 days prior to administration of Cu-64 SARTATE:
Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
Diagnosis of recurrent or progressive histologically confirmed WHO grade I-III meningioma which has failed standard of care therapies. Patients will be considered to have failed standard care when they have disease that is progressing despite standard treatment (primarily radiotherapy) or where, in the opinion of their treating physician, further standard therapy is considered to be of sufficiently high risk of complication as to warrant consideration of alternate therapies.
Male participants must agree to use contraception methods from Day 0 through to 4 weeks after the last dose of Cu-67 SARTATE.
A female participant is eligible to participate if she is of:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Schembri, MD | Royal North Shore Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | Sydney | New South Wales | 2065 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36460344 | Derived | Bailey DL, Willowson KP, Harris M, Biggin C, Aslani A, Lengkeek NA, Stoner J, Eslick ME, Marquis H, Parker M, Roach PJ, Schembri GP. 64Cu Treatment Planning and 67Cu Therapy with Radiolabeled [64Cu/67Cu]MeCOSar-Octreotate in Subjects with Unresectable Multifocal Meningioma: Initial Results for Human Imaging, Safety, Biodistribution, and Radiation Dosimetry. J Nucl Med. 2023 May;64(5):704-710. doi: 10.2967/jnumed.122.264586. Epub 2022 Dec 2. |
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| ID | Term |
|---|---|
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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| ID | Term |
|---|---|
| C000706138 | 64Cu-SARTATE |
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Absorbed doses (mSv/MBq) will be calculated using SPECT/CT scans acquired at 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE. |
| 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE. |
| Maximum and mean SUV of Cu-64 SARTATE in target organs and SSTR binding lesions. | Maximum and mean SUV will be calculated using PET/CT scans acquired at 1, 4 and 24 hours post administration of Cu-64 SARTATE. | 1, 4 and 24 hours post administration of Cu-64 SARTATE. |
| Maximum and mean SUV of Cu-67 SARTATE in target organs and SSTR binding lesions. | Maximum and mean SUV will be calculated using SPECT/CT scans acquired at 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE. | 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE. |
| Activity of Cu-64 SARTATE in target and non-target organs and SSTR binding lesions as a percentage of the administered dose. | The percentage of the administered dose will be calculated using PET/CT scans acquired at 1, 4 and 24 hours post administration of Cu-64 SARTATE. | 1, 4 and 24 hours post administration of Cu-64 SARTATE. |
| Activity of Cu-67 SARTATE in target and non-target organs and SSTR binding lesions as a percentage of the administered dose. | The percentage of the administered dose will be calculated using SPECT/CT scans acquired at 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE. | 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE. |
| Objective Response | Objective response to therapy will be assessed according to the RANO Response Criteria for Meningioma, as measured by MRI and clinical status. | At 6 weeks post second administration of Cu-67 SARTATE, as well as at 6 and 12 weeks following the fourth administration. |
| Qualitative analysis of PET/CT scans post administration of Cu-64 SARTATE. | Qualitative analysis of PET/CT scans to identify uptake patterns. | 1, 4 and 24 hours post administration of Cu-64 SARTATE. |
| Qualitative analysis of SPECT/CT scans post administration of Cu-67 SARTATE. | Qualitative analysis of SPECT/CT scans to identify uptake patterns. | 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE. |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |