Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06148636 | A Safety Study of 212Pb-VMT-alpha-NET in Patients With Neuroendocrine Tumors | EARLY_PHASE1 | ACTIVE NOT_RECRUITING | 24 | — | — | Nov 10, 2023 | Dec 31, 2027 | Nov 4, 2025 | 1 | United States |
Determine the recommended phase 2 dose for therapy with \[212Pb\]VMT-Α-NET administered intravenously to patients with neuroendocrine tumors that have progressed despite therapy.
| Arm | Type | Description |
|---|---|---|
| -1 Dose Level | EXPERIMENTAL | This dose level is used if the starting dose level is deemed to have unacceptable toxicity. Participants are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 200 cGy. |
| Cohort 1 | EXPERIMENTAL | This is the starting dose level for participants. Participants are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 350 cGy. |
| Cohort 2 | EXPERIMENTAL | If the participants from Cohort 1 tolerate therapy, new participants are enrolled and are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 600 cGy. |
| Cohort 3 | EXPERIMENTAL | If the participants from Cohort 2 tolerate therapy, new participants are enrolled and are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 810 cGy. |
| Cohort 4 | EXPERIMENTAL | If the participants from Cohort 3 tolerate therapy, new participants are enrolled and are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 1050 cGy. |
| Name | Type | Description |
|---|---|---|
| [212Pb] VMT-α-NET | DRUG | Up to 2 infusions with \[212Pb\] VMT-α-NET, each infusion separated by at least 8 weeks. During each infusion, the participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage. |
| [203Pb] VMT-α-NET SPECT/CT | DIAGNOSTIC_TEST | The \[203Pb\] VMT-α-NET SPECT/CT is performed for all participants to determine trial eligibility as well as for the calculations to determine the estimated radiation dose to kidneys. This involves three imaging sessions of about 2 hours each over 2 days. The participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage at the time they receive the injection of . \[203Pb\] VMT-α-NET, a radioactive tracer drug. |
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 cyt...