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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06617169 | Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors | PHASE1 | RECRUITING | 12 | — | — | Oct 8, 2024 | Jan 1, 2027 | May 21, 2025 | 1 | Australia |
Dose-limiting toxicities (DLT) are at least possibly related to MNPR-101-PCTA-177Lu and occur within 6 weeks of C1D1. Participants experiencing a DLT will not receive any further doses. Participants will continue study participation through the 12-week post final dose Safety Visit.
The safety profile of MNPR-101-PCTA-177Lu will be determined through assessment of adverse event (AE) type, incidence, severity, time of appearance, and related causes (detected by physical explorations and laboratory tests). Adverse events will be graded and tabulated using NCI CTCAE v5.0.
| Arm | Type | Description |
|---|---|---|
| Level 0 - MNPR-101-PCTA-177Lu 480 MBq | EXPERIMENTAL | - |
| Level 1 - MNPR-101-PCTA-177Lu 960 MBq | EXPERIMENTAL | - |
| Level 2 - MNPR-101-PCTA-177Lu 1440 MBq | EXPERIMENTAL | - |
| Level 3 - MNPR-101-PCTA-177Lu 1920 MBq | EXPERIMENTAL | - |
| Level 4 - MNPR-101-PCTA-177Lu 2240 MBq | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MNPR-101-PCTA-177Lu | DRUG | MNPR-101-PCTA-177Lu administered intravenously over approximately 20 minutes, followed by a normal saline flush. Dosing will occur on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1. |
Inclusion Criteria: 1. Participated in the MNPR-101-D001 study. 2. Females of childbearing potential must have a negative serum pregnancy test at time of screening and a negative urine pregnancy test on Day 1 prior to study drug administration if screening is \>7 days prior to Day 1. A rapid serum ...