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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, ...
| 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 |
PAS-004 is an investigational small molecule being developed for oncology indications involving NF1 and RAS mutations. It is being studied in patients with advanced solid tumors that have RAS, NF1, or RAF mutations, and in adults with neurofibromatosis type 1 who have plexiform neurofibromas. It is currently in Phase 1 clinical development.
PAS-004 targets MEK, a kinase enzyme in the RAS/MAPK signaling pathway. By inhibiting MEK, PAS-004 is designed to interfere with signaling that drives tumor growth in cancers with RAS or NF1 mutations. This mechanism is relevant to the Phase 1 trials evaluating PAS-004 in advanced solid tumors and NF1-related plexiform neurofibromas.
PAS-004 is being developed by Pasithea Therapeutics Corp., a biopharmaceutical company traded on Nasdaq under the ticker symbol KTTA. The company is conducting Phase 1 clinical trials of PAS-004 in patients with advanced solid tumors and in adults with neurofibromatosis type 1 and plexiform neurofibromas.
PAS-004 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The FDA has granted PAS-004 Fast Track designation, Orphan Drug designation, and Rare Pediatric Disease designation for its intended indications.
PAS-004 is being studied in two Phase 1 trials. NCT06299839 is evaluating PAS-004 in patients with advanced solid tumors with RAS, NF1, or RAF mutations, enrolling 48 participants in the United States, Bulgaria, and Romania. NCT06961565 is studying PAS-004 in adults with neurofibromatosis type 1 and plexiform neurofibromas, enrolling 56 participants in the United States, Australia, and South Korea.
Yes, PAS-004 Capsules and PAS-004 Tablets are alternative names for the same drug, PAS-004. The drug is being developed in oral formulations for the treatment of cancers and conditions associated with NF1 and RAS mutations.