A Safety Study of 212Pb-VMT-alpha-NET in Patients With Neuroendocrine Tumors (NCT06148636) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
A Safety Study of 212Pb-VMT-alpha-NET in Patients With Neuroendocrine Tumors
United States24 participantsStarted 2023-11-10
Plain-language summary
This is a safety study to determine the recommended dose to test in clinical trials. The study involves two treatments with 212Pb (212-lead) VMT-α-NET. This is a safety study only; it will most likely not provide therapeutic benefit.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Ability to understand and willingness to provide informed consent
* Stated willingness to comply with all study procedures and availability for duration of study
* Aged ≥ 18 years to 80 years at the time of study drug administration
* Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2)
* Disease not amenable to curative intent treatment (e.g., surgery) and in addition, has shown either clinical or radiographic progression on all available therapies known to confer clinical benefit in the opinion of the referring physician. If a patient is suspected of experiencing a clinical non-response to current treatment (i.e., the patients clinical symptomatology has not improved despite treatment) the patient may be included if confirmed by the study investigator.
* Prior peptide receptor radionuclide therapy (PRRT)
* Positive somatostatin receptor (SSTR) PET/CT utilizing an FDA approved agent within 12 months prior to anticipated day 1 of treatment demonstrating SSTR positive tumor sites.
* ≥1 evaluable site of disease measuring ≥ 1.0 cm in diameter on CT or MRI as measured per RECIST
* Adequate performance status (ECOG of 0 or 1; or KPS of ≥70).
* No other active malignancy that requires immediate treatment. Slow growing concurrent cancers (such as prostate cancer) are acceptable with appropriate documentation from their treating oncologists for that pri…
What they're measuring
1
Determine recommended therapeutic dose of [212Pb] VMT-α-NET
Timeframe: From study day 1 through 6 months post-treatment