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Also known as PAS-004 Capsules, PAS-004 Tablets
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, ...
Top 4 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Tango Therapeutics, Inc. | TNGX | 1 | PHASE1 | TNG462 |
| Adlai Nortye Ltd. Sponsored ADR | ANL | 2 | PHASE1 | AN9025, AN4035 |
| Pasithea Therapeutics Corp. | KTTA | 1 | PHASE1 | PAS-004 |
| BeOne Medicines Ltd. Sponsored ADR | ONC | 1 | PHASE1 | BG-85738, Tislelizumab |
PAS-004 is an investigational oral small molecule being studied in adults with NF1 mutation and RAS mutation driven cancers. Its clinical program includes neurofibromatosis type 1 related plexiform neurofibromas and advanced solid tumors. It has not been approved for any indication and remains in Phase 1 development.
PAS-004 targets MEK, a kinase in the RAS/MAPK signaling pathway. MEK inhibition is intended to block signaling driven by upstream mutations such as NF1 and RAS alterations. PAS-004 is a small molecule MEK inhibitor in Phase 1 testing.
PAS-004 is being developed by Pasithea Therapeutics Corp., which trades under the ticker KTTA. The company is the sponsor of the Phase 1 clinical program evaluating PAS-004 in biomarker selected adult patient populations.
PAS-004 is in Phase 1 clinical development. It is investigational and has not received FDA approval. The program includes two recruiting Phase 1 trials, one in NF1 related plexiform neurofibromas and one in advanced solid tumors with RAS, NF1, or RAF mutations.
PAS-004 is being evaluated in two recruiting Phase 1 trials. NCT06961565 studies PAS-004 in adults with neurofibromatosis type 1 and plexiform neurofibromas across the United States, Australia, and South Korea. NCT06299839 studies PAS-004 in patients with advanced solid tumors in the United States, Bulgaria, and Romania.
Yes. PAS-004 Capsules and PAS-004 Tablets are alternative names for PAS-004, the same investigational MEK inhibitor developed by Pasithea Therapeutics Corp. under ticker KTTA. Searches for any of these names refer to the same Phase 1 drug candidate.