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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04883775 | Study of a New Technique for Imaging Pancreatic Cancer | PHASE1 | COMPLETED | 4 | — | — | May 10, 2021 | Jan 27, 2025 | Jan 30, 2025 | 7 | United States |
assessed by CTCAE v4.0
will be determined by measuring radiation exposure for key organs and tissues
| Arm | Type | Description |
|---|---|---|
| 89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging | EXPERIMENTAL | All subjects will receive a single, fixed, intravenous dose of MVT-2163, consisting of 3 mg (nominal mass - actual mass administered will likely vary between 2.0 and 2.5 mg) of MVT-2163 radiolabeled from 5 mCi to no less than 1.0 mCi (adjusted as of 16-Mar 2017) of 89Zr.Cohort 1 subjects will receive MVT-2163, with no MVT-5873 pre-dosing. Subjects in subsequent cohorts 2 and 3 will receive a dose of MVT-5873 15 minutes, \~ 2 hours, and \~4 hours prior to administration of MVT-2163. Future cohorts 4 and 5 may evaluate alternate time frames. Other cohorts may evaluate administration of MVT-5873 one week prior (D-7) to the day of MVT-2163 administration and a second administration of MVT-5873 the day of (D0) MVT-2163 administration. The re-entry (RE) and pre-surgery (PS) cohorts will administer MVT-2163 3 ± 1 hour after administration of MVT-5873. |
| Name | Type | Description |
|---|---|---|
| MVT-2163 | DRUG | MVT-2163 is administered intravenously as a PET imaging agent. |
| MVT-5873 | DRUG | MVT-5873 will be administered intravenously over at least 60 minutes. |
Inclusion Criteria: PART I : ESCALATION, EXPANSION, RE-ENTRY COHORTS: * Histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies PART II: PRE-SURGERY COHORT ONLY: * Patients with biopsy-p...