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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.

Compiled by PlainTrial · August 8, 2026

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

NCT06299839: Recruiting Phase 1 study of Advanced Solid Tumors and RAS Mutation, sponsored by Pasithea Therapeutics.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Pre-defined DLTs will be assessed for dose escalation and expansion determinations.

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

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

Pasithea Therapeutics

2 total trials

What NCT06299839 shows while recruiting

NCT06299839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (76% lower).

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 lists 7 locations in 3 states (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.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumors

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.

Where NCT06299839's enrollment target sits among peer trials

48 103rd of 144 higher than 41 of 144 other Advanced Solid Tumors trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumors 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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Source: ClinicalTrials.gov NCT06299839, the US trial registry maintained by the National Library of Medicine. NCT06299839 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.