Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PAS-004 · 2 trials · 8 indications
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).
Pre-defined DLTs will be assessed for dose escalation and expansion determinations.
The number and severity of AEs will be evaluated for dosing cohorts to inform dose escalation and expansion decisions, and support selection of a preliminary recommended phase 2 dose (RP2D).
The number and severity of AEs leading to discontinuation of study drug will be evaluated for dosing cohorts to inform dose escalation and expansion decisions, and support selection of a preliminary recommended phase 2 dose (RP2D).
Lab parameters will be evaluated for to assess the safety profile of the study drug, and support selection of a preliminary recommended phase 2 dose (RP2D).
Lab parameters will be evaluated for to assess the safety profile of the study drug, and support selection of a preliminary recommended phase 2 dose (RP2D).
| 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 |
| PAS-004 Capsules | EXPERIMENTAL | Sequential dose escalation: 2 mg, 4 mg, 8 mg, 15 mg, 22 mg, 30 mg, 37 mg, and 45 mg |
| PAS-004 Tablets | EXPERIMENTAL | A single cohort at the 4mg dose using tablet formulation of PAS-004 |
| 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. |
| PAS-004 Capsules | DRUG | A mitogen-activated protein kinase/extracellular signal-regulated kinase kinase (MAPK/ERK kinase, or MEK) 1/2 inhibitor presented in 1 mg, 4mg, and 10 mg strength capsules, 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 |
| Pasithea Therapeutics Corp. | KTTA | 1 | PHASE1 | PAS-004 |
| Adlai Nortye Ltd. Sponsored ADR | ANL | 1 | PHASE1 | AN9025 |
| Myriad Genetics, Inc. | MYGN | 1 | PHASE1 | Melphalan, BCNU, Vitamin B12B, Vitamin C |