Study of PAS-004 for Advanced Solid Tumors with Specific Mutations
This study is testing a new medication called PAS-004 in people with advanced solid tumors that have specific genetic changes (mutations) in RAS, NF1, or RAF genes. PAS-004 is a type of drug called a MEK 1/2 inhibitor, which works by blocking certain signals that can help cancer cells grow. The main goals are to find out how well people can tolerate different doses of PAS-004 and what side effects it might cause. You would take PAS-004 by mouth once a day. The study plans to enroll 48 participants aged 18 or older. To join, you need to have one of the specific mutations (BRAF or NF1) in your tumor.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 48 participants.
- What's involved
- You will have regular visits with the study doctor, and undergo tests and exams to check your health and safety. You will take PAS-004 by mouth once a day in 28-day cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health and any side effects will be monitored for 30 days after you stop taking PAS-004.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PAS-004 in Patients With Advanced Solid Tumors
At a glance
Conditions
NCT06299839
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Institute of Oncology Bucharest Prof. Dr. Alexandru Trestioreanu
Bucharest, Romaniastudy coordinator listed
Recruiting
Institute of Oncology Prof. Dr. Ion Chiricuta
Cluj-Napoca, Romaniastudy coordinator listed
Recruiting
MBAL Sveta Sofia
Sofia, Bulgariastudy coordinator listed
Recruiting
NEXT Oncology
Austin, Texasno site contact published
Active, not recruiting
NEXT Oncology
Irving, Texasno site contact published
Active, not recruiting
NEXT Oncology
San Antonio, Texasno site contact published
Active, not recruiting
NEXT Oncology
Fairfax, Virginiano site contact published
Active, not recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Tiago R Marques, MD · STUDY_DIRECTOR · Pasithea Therapeutics Corp.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Evaluation of dose limiting toxicities (DLTs)Day 1 through Day 35 (Cycle 1)
Pre-defined DLTs will be assessed for dose escalation and expansion determinations.
- Evaluation of adverse events (AEs)Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug
The number and severity of AEs will be evaluated for dosing cohorts to inform dose escalation and expansion decisions, and support selection of a preliminary recommended phase 2 dose (RP2D).
- Evaluation of AEs leading to discontinuation of investigational product (IP), PAS-004.Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug
The number and severity of AEs leading to discontinuation of study drug will be evaluated for dosing cohorts to inform dose escalation and expansion decisions, and support selection of a preliminary recommended phase 2 dose (RP2D).
- Evaluation of hematology laboratory parametersScreening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug
Lab parameters will be evaluated for to assess the safety profile of the study drug, and support selection of a preliminary recommended phase 2 dose (RP2D).
- Evaluation of clinical chemistry laboratory parametersScreening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug
Lab parameters will be evaluated for to assess the safety profile of the study drug, and support selection of a preliminary recommended phase 2 dose (RP2D).