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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: Recruiting Phase 1 study of Neurofibroma Plexiform and NF1 Mutation, sponsored by Pasithea Therapeutics.

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, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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).

Conditions Studied

Neurofibroma Plexiform NF1 Mutation Neurofibromatosis Type 1 (NF1) Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs)

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

FieldValue
Enrollment Target 56 participants
Start Date 2025-05-30
Est. Completion 2027-12
Phase Phase 1
Pasithea Therapeutics

2 total trials

What NCT06961565 shows while recruiting

NCT06961565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

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 lists 5 locations in 4 states (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.

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Where NCT06961565's enrollment target sits among peer trials

56 903rd of 2000 higher than 1,083 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06961565

Source: ClinicalTrials.gov NCT06961565, the US trial registry maintained by the National Library of Medicine. NCT06961565 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.