Actively Recruiting
PAS-004 in Patients With Advanced Solid Tumors
Led by Pasithea Therapeutics Corp. · Updated on 2025-12-03
48
Participants Needed
7
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
PAS-004 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and comply with study requirements
- At least 18 years old at time of consent
- Able to swallow oral medication
- Histologically or cytologically diagnosed advanced solid tumor driven by MAPK pathway with all of the following:
- Tumor not surgically removable
- Failed or ineligible for standard therapy
- No available treatments with known benefit
- Documented RAS, NF1, or RAF mutation (RAF mutation patients must have failed prior BRAF/MEK inhibition)
- Agree to provide tumor tissue for genetic testing if no prior results available
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Estimated life expectancy of at least 12 weeks
- Adequate organ function as shown by specific lab values (bilirubin, AST, ALT, albumin, creatinine clearance, ANC, platelets, hemoglobin)
- Agree to maintain abstinence or use effective contraception during treatment and for 90 days after last dose; male patients agree not to donate sperm during this time
You will not qualify if you...
- Participation in another therapeutic clinical trial within 3 weeks before enrollment
- Received chemotherapy, radiotherapy, major surgery, targeted therapy, immunotherapy, or other cancer treatment within 21 days before enrollment
- Known or active central nervous system metastases, except:
- Untreated brain metastases ≤30 mm that are asymptomatic and stable after treatment
- No corticosteroid use within 7 days prior to study drug
- Exclude confirmed leptomeningeal disease
- Unresolved toxicity from prior cancer therapy greater than Grade 2 (except alopecia and neurotoxicity restored to Grade 2 or below)
- Use of strong cytochrome P450 (CYP3A) inhibitors or inducers within 14 days before study drug
- Use of QT prolonging medications within 7 days before study drug
- Active swallowing problems, digestive disease, or malabsorption affecting drug absorption
- Previous or current serious eye conditions including retinal vein issues or active glaucoma
- Active interstitial pneumonia or significant radiation pneumonitis
- Impaired cardiac function or disease including prolonged QTc, severe heart failure, or significant arrhythmias
- Pregnant or breastfeeding females
- Known allergy or severe reaction to the study drug or its components
- Active infections including bacterial, fungal, viral, hepatitis B or C, or HIV infection
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Trial Site Locations
Total: 7 locations
1
NEXT Oncology
Austin, Texas, United States, 78758
Active, Not Recruiting
2
NEXT Oncology
Irving, Texas, United States, 75039
Active, Not Recruiting
3
NEXT Oncology
San Antonio, Texas, United States, 78229
Active, Not Recruiting
4
NEXT Oncology
Fairfax, Virginia, United States, 22031
Active, Not Recruiting
5
MBAL Sveta Sofia
Sofia, Bulgaria, 1404
Actively Recruiting
6
Institute of Oncology Bucharest Prof. Dr. Alexandru Trestioreanu
Bucharest, Romania, 022328
Actively Recruiting
7
Institute of Oncology Prof. Dr. Ion Chiricuta
Cluj-Napoca, Romania, RO-400015
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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