Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06961565 · ClinicalTrials.gov registry record · Phase 1
PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas
A Phase 1 study of Neurofibroma Plexiform and NF1 Mutation, sponsored by Pasithea Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 5
- Study locations
NCT06961565 is a Phase 1 study of Neurofibroma Plexiform and NF1 Mutation that is actively recruiting participants, run by Pasithea Therapeutics. The registered enrollment target is 56 participants. The trial reports 5 study locations across 4 states.
The verdict
NCT06961565, a Phase 1 study of Neurofibroma Plexiform and NF1 Mutation, is actively recruiting participants, sponsored by Pasithea Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 5
- Study locations
Study Summary
The main purpose of this clinical trial is to test PAS-004 in people with at least one symptomatic plexiform neurofibroma due to Neurofibromatosis Type 1 (NF1). The main questions it aims to answer are: * How well participants are able tolerate different doses of PAS-004, and * What side effects PAS-004 might have. This study will have two parts, Part A and Part B. The main goal of Part A of this study is to learn more about how participants tolerate different doses of PAS-004, and what side effects PAS-004 might have. What we learn from Part A of the study will help decide what doses of the study drug (PAS-004) should be used in Part B of the study, and if it is safe. In Part B, two different doses from Part A will be tested. The main goal of this part of the study is to keep studying any side effects of PAS-004 at those two dose levels, and to learn more about if the doses picked for this part of the study might have an effect on plexiform neurofibromas. Participants in Part A of the study who were taking doses selected for Part B may be able to continue on to Part B and keep taking the same dose of PAS-004 for 6 more months. Study participants in both parts will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety, including blood draws and MRIs. Everyone participating in the study will take PAS-004 by mouth once a day during the study, in 28-day cycles. Participants will be asked to keep a diary to record their daily dose of study drug. Participants will continue on daily PAS-004 for up to 6 months, or until: * They decide to withdraw from the study, or * They experience unacceptable side effects, or * Their disease progresses, or another illness interferes with taking the study drug, or * The sponsor selects a dose level to study further in the next part of the study, or * The sponsor stops the study.
Conditions Studied
Interventions
- DRUG PAS-004 Tablets
Study Locations (5)
Other
- Asan Medical Center - Seoul
- Severance Hospital, Yonsei University Health System - Sinchŏn-dong
Alabama
- University of Alabama at Birmingham - Birmingham
New South Wales
- Royal North Shore Hospital - St Leonards
Victoria
- Peter MacCallum Cancer Centre - Melbourne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2025-05-30 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06961565
The ClinicalTrials.gov registry entry for NCT06961565 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pasithea Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Neurofibroma Plexiform appearing as the primary indexed condition, and to 1 intervention - of which PAS-004 Tablets is the first listed.
NCT06961565 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Other, Alabama, New South Wales.
Frequently Asked Questions
What is clinical trial NCT06961565 about?
NCT06961565 is a clinical study titled "PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas". The main purpose of this clinical trial is to test PAS-004 in people with at least one symptomatic plexiform neurofibroma due to Neurofibromatosis Type 1 (NF1). The main questions it aims to answer are: * How well participants are able tolerate different doses of PAS-004, and * What side effects PA...
What is the current status of trial NCT06961565?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2025-05-30. Estimated completion is 2027-12.
What conditions does trial NCT06961565 study?
This clinical trial studies the following conditions: Neurofibroma Plexiform, NF1 Mutation, Neurofibromatosis Type 1 (NF1), Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs).
What interventions are being tested in trial NCT06961565?
The interventions under investigation include: PAS-004 Tablets (DRUG).
Who is sponsoring clinical trial NCT06961565?
This trial is sponsored by Pasithea Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06961565 being conducted?
This trial has 5 study locations across Alabama, New South Wales, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neurofibroma Plexiform
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
RECRUITING · Phase 1
-
AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors
ACTIVE NOT RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.