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NCT06299839 · ClinicalTrials.gov registry record · Phase 1

PAS-004 in Patients With Advanced Solid Tumors

A Phase 1 study of Advanced Solid Tumors and RAS Mutation, sponsored by Pasithea Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
48
Enrollment target
7
Study locations

NCT06299839 is a Phase 1 study of Advanced Solid Tumors and RAS Mutation that is actively recruiting participants, run by Pasithea Therapeutics. The registered enrollment target is 48 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (76% lower). The trial reports 7 study locations across 3 states.

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The verdict

NCT06299839, a Phase 1 study of Advanced Solid Tumors and RAS Mutation, is actively recruiting participants, sponsored by Pasithea Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
48 participants
Enrollment target
7
Study locations

Study Summary

The main purpose of this clinical trial is to test PAS-004 in people with advanced solid tumors with rat sarcoma virus (RAS), neurofibromatosis type I (NF1), or rapidly accelerated fibrosarcoma (RAF) mutations. 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. Study participants will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety. Everyone participating in the study will take PAS-004 by mouth as a single dose, followed by one week observation, then once a day during the study, in 28-day cycles. Participants will continue on daily PAS-004 for up to 2 years, 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 sponsors stops the study.

Conditions Studied

Advanced Solid Tumors RAS Mutation NF1 Mutation RAF Mutation

Interventions

  • DRUG PAS-004 Tablets
  • DRUG PAS-004 Capsules

Study Locations (7)

Texas

  • NEXT Oncology - Austin
  • NEXT Oncology - Irving
  • NEXT Oncology - San Antonio

Other

  • MBAL Sveta Sofia - Sofia
  • Institute of Oncology Bucharest Prof. Dr. Alexandru Trestioreanu - Bucharest
  • Institute of Oncology Prof. Dr. Ion Chiricuta - Cluj-Napoca

Virginia

  • NEXT Oncology - Fairfax

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2024-02-29
Est. Completion 2027-02
Phase Phase 1

Sponsor

Pasithea Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06299839

The ClinicalTrials.gov registry entry for NCT06299839 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (76% lower). The listed sponsor is Pasithea Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which PAS-004 Tablets is the first listed.

NCT06299839 reports 7 study locations spanning 3 distinct geographic areas - top geographies include Texas, Other, Virginia.

Frequently Asked Questions

What is clinical trial NCT06299839 about?

NCT06299839 is a clinical study titled "PAS-004 in Patients With Advanced Solid Tumors". The main purpose of this clinical trial is to test PAS-004 in people with advanced solid tumors with rat sarcoma virus (RAS), neurofibromatosis type I (NF1), or rapidly accelerated fibrosarcoma (RAF) mutations. The main questions it aims to answer are: * How well participants are able tolerate diff...

What is the current status of trial NCT06299839?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2024-02-29. Estimated completion is 2027-02.

What conditions does trial NCT06299839 study?

This clinical trial studies the following conditions: Advanced Solid Tumors, RAS Mutation, NF1 Mutation, RAF Mutation.

What interventions are being tested in trial NCT06299839?

The interventions under investigation include: PAS-004 Tablets (DRUG), PAS-004 Capsules (DRUG).

Who is sponsoring clinical trial NCT06299839?

This trial is sponsored by Pasithea Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06299839 being conducted?

This trial has 7 study locations across Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.