PAS-004 for Advanced Solid Tumors

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pasithea Therapeutics Corp.

Must not be taking: CYP3A inhibitors, QTc prolonging

Disqualifiers: CNS metastases, Cardiac disease, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PAS-004 for individuals with advanced solid tumors that have specific genetic changes, including RAS, NF1, or RAF mutations. The main goals are to assess how well different doses are tolerated and to identify any side effects. Participants will take the medication daily and attend regular check-ups. This trial may suit those whose tumors cannot be surgically removed, have tried other treatments without success, and have no other available treatment options. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain medications like strong CYP3A inhibitors or inducers, or QTc interval prolonging medications close to starting the trial. It's best to discuss your current medications with the study doctor.

Is there any evidence suggesting that PAS-004 is likely to be safe for humans?

Research has shown that PAS-004 is generally safe and well-tolerated in people with certain advanced cancers. This drug, a MEK inhibitor, blocks signals that help cancer cells grow. Studies have found that patients tolerate this medication well. Due to its positive safety record, the Safety Review Committee recommended testing higher doses in the trials.

While some side effects might occur, they are usually manageable and not serious enough to stop treatment for most patients. Regular check-ups are important for participants to monitor any side effects. Overall, early results suggest that PAS-004 could be a promising option for those with specific genetic changes in their tumors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about PAS-004 for advanced solid tumors because it offers a novel approach compared to standard chemotherapy and targeted therapies. Unlike traditional treatments that often focus on attacking cancer cells directly, PAS-004 might work by interfering with specific pathways that are crucial for tumor growth and survival. Furthermore, PAS-004 is being tested in both capsule and tablet formulations, which could offer flexibility in dosing and administration, making it potentially more convenient for patients. This innovative approach and versatility could pave the way for more personalized and effective cancer treatment options.

What evidence suggests that PAS-004 might be an effective treatment for advanced solid tumors?

Research has shown that PAS-004 may help treat advanced solid tumors. In this trial, participants will receive either PAS-004 Capsules or PAS-004 Tablets. Studies have found that PAS-004 can be effective for patients who have tried many other treatments without success. This drug targets a pathway often involved in tumor growth. Early data suggests that PAS-004 is safe and tolerable, with some patients responding well to the treatment. While more research is needed, these early findings offer hope for those with hard-to-treat cancers. ^{1 2 3 5 6}

Who Is on the Research Team?

Tiago R Marques, MD

Principal Investigator

Pasithea Therapeutics Corp.

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have specific genetic changes (RAS, NF1, or RAF mutations). Participants should be able to swallow pills and attend regular study visits. They must not have other medical conditions that could interfere with the study or be taking certain medications.

Inclusion Criteria

I can swallow pills.

I agree to use effective birth control or remain abstinent during and for 90 days after treatment.

I understand the study's goals, methods, benefits, risks, and have given written consent.

Exclusion Criteria

I haven't had cancer treatment or major surgery in the last 4 weeks.

I have conditions that affect how my body absorbs medication.

Participation in another therapeutic clinical trial within 4 weeks of enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PAS-004 by mouth as a single dose, followed by one week observation, then once a day during the study, in 28-day cycles

Up to 2 years

Regular visits to the study doctor

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days after discontinuation of study drug

Extension

Participants may continue treatment until they decide to withdraw, experience unacceptable side effects, or their disease progresses

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• PAS-004

Trial Overview PAS-004 is being tested in this trial. It's a medication taken by mouth as a single dose initially, then daily in 28-day cycles for up to two years unless side effects become too severe or the disease gets worse. The goal is to find out how much of PAS-004 can be safely taken and what its potential side effects are.

How Is the Trial Designed?

Group I: PAS-004 Tablets Experimental Treatment 1 Intervention

A single cohort at the 4mg dose using tablet formulation of PAS-004

Group II: PAS-004 Capsules Experimental Treatment 1 Intervention

Sequential dose escalation: 2 mg, 4 mg, 8 mg, 15 mg, 22 mg, 30 mg, 37 mg, and 45 mg

Who Is Running the Clinical Trial?

Pasithea Therapeutics Corp.

Lead Sponsor

Trials

1

Recruited

50+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06299839

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) ...

2. ir.pasithea.com ir.pasithea.com/news-events/press-releases/detail/122/pasithea-therapeutics-presents-updated-interim-data-from

Pasithea Therapeutics Presents Updated Interim Data from ... PAS-004 demonstrates preliminary clinical activity as a monotherapy in patients with heavily pre-treated, refractory solid tumors.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3125

Phase I dose-escalation study of the safety and ... PAS-004 was developed to reduce metabolic liabilities and overcome the limited exposure and stability of known MEK inhibitors. We report initial ...

4. onclive.com onclive.com/view/pas-004-has-tolerable-safety-profile-and-preliminary-efficacy-in-mapk-driven-solid-tumors

PAS-004 Has Tolerable Safety Profile and Preliminary ... The MEK inhibitor PAS-004 is safe, tolerable, and generated early efficacy signals in patients with MAPK pathway–driven advanced cancers.

5. clin.larvol.com clin.larvol.com/trial-detail/NCT06299839

PAS-004 in Patients With Advanced Solid Tumors | "PAS-004 demonstrates preliminary clinical activity as a monotherapy in patients with heavily pre-treated, refractory solid tumors; One patient in cohort 4A ( ...

6. ir.pasithea.com ir.pasithea.com/news-events/press-releases/detail/114/pasithea-therapeutics-announces-positive-safety-review

Press Releases The external Safety Review Committee recommended that the Company's Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to Cohort 6, 30mg ...