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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06961565 | PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas | PHASE1 | RECRUITING | 56 | — | — | May 30, 2025 | Dec 1, 2027 | Dec 4, 2025 | 5 | United States, Australia +1 |
Endpoint/Outcome Measures: Number of participants with dose-limiting toxicities (DLTs), with Adverse Events (AEs), AEs leading to interruption or discontinuation of study drug, with clinically significant findings on clinical laboratory tests, with abnormal cardiac and visual function exams using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
Endpoint/Outcome Measures: Number of participants with dose-limiting toxicities (DLTs), with Adverse Events (AEs), AEs leading to interruption or discontinuation of study drug, with clinically significant findings on clinical laboratory tests, with abnormal cardiac and visual function exams using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Sequential dose escalation: 4 mg, 8 mg, 12 mg, and 18 mg |
| Part B | EXPERIMENTAL | Two parallel cohorts dosing at 2 levels selected based on Part A safety results |
| Name | Type | Description |
|---|---|---|
| PAS-004 Tablets | DRUG | A mitogen-activated protein kinase/extracellular signal-regulated kinase kinase (MAPK/ERK kinase, or MEK) 1/2 inhibitor presented in 1m and 4mg strength tablets, intended for oral administration once daily. |
Inclusion Criteria: 1. Participant is capable of providing informed consent, which includes compliance with the requirements, prohibitions and restrictions listed in the informed consent form. 2. Participant has been informed both verbally and in writing about the objectives of the clinical study, ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Tango Therapeutics, Inc. | TNGX | 1 | PHASE1 | TNG462, RMC-9805, RMC-6236, mFOLFIRINOX, gemcitabine/nab-paclitaxel |
| Myriad Genetics, Inc. | MYGN | 1 | PHASE1 | Melphalan, BCNU, Vitamin B12B, Vitamin C |
| Adlai Nortye Ltd. Sponsored ADR | ANL | 1 | PHASE1 | AN9025 |
| Pasithea Therapeutics Corp. | KTTA | 1 | PHASE1 | PAS-004 |