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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05538572 | A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors | PHASE1 | COMPLETED | 22 | — | — | Dec 27, 2022 | Jun 26, 2024 | Jul 1, 2024 | 13 | United States, Singapore |
Dose limiting toxicity will be evaluated over the 28-day observation period
Safety and tolerability will be evaluated by incidence of DLTs, laboratory measurements, severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
The MTD/RP2D will be established for further investigation in participants with advanced solid tumors
| Arm | Type | Description |
|---|---|---|
| PRT3645 | EXPERIMENTAL | PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned |
| Name | Type | Description |
|---|---|---|
| PRT3645 | DRUG | PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned |
Inclusion Criteria: * Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy that have either progress or ineligible for standard of care therapy: 1. HR+ and HER2- or HR+ and HER2+ breast cancer 2. Recurrent GBM (IDH wild type) or CDKN2A/B homozygous deleted IDH-mut...