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New treatment option for RAS Mutation
Official title PAS-004 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06299839
What this study is testing
What is PAS-004 Capsules?
PAS-004 Capsules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ras mutation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Capable of giving signed informed consent which includes compliance with the requirements, prohibitions and restrictions listed in the informed...
- Patient has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits, the...
- Patient must be at least 18 years of age at the time of signing the ICF.
- Patient must be able to swallow oral medication.
- Patient with histologically or cytologically diagnosed mitogen-activated protein kinase (MAPK) pathway driven advanced solid tumors with all of the...
You likely can't join if
- Participation in another therapeutic clinical trial within 3 weeks of enrollment.
- Having received chemotherapy, radiotherapy, major surgery, targeted therapy, immunotherapy, or other antitumor treatment within 21 days of enrollment...
- Known or active central nervous system metastases.
- Patients with untreated brain metastases ≤ 30 mm that are asymptomatic, do not have significant edema, and do not require steroids or anti-seizure...
- Patients with previously treated brain metastases may participate provided they are stable after treatment and without evidence of progression by...
- Patients with confirmed leptomeningeal disease are to be excluded.
See the full eligibility criteria
Who can join
- Capable of giving signed informed consent which includes compliance with the requirements, prohibitions and restrictions listed in the informed consent form (ICF).
- Patient has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits, the potential risks, and the discomfort to which they may be exposed and has...
- Patient must be at least 18 years of age at the time of signing the ICF.
- Patient must be able to swallow oral medication.
- Patient with histologically or cytologically diagnosed mitogen-activated protein kinase (MAPK) pathway driven advanced solid tumors with all of the following characteristics:
- Tumor cannot be surgically resected
- Patient has failed or is ineligible for standard of care therapy
- Patient has no available treatment options with known clinical benefit
- Documented evidence of rat sarcoma virus (RAS), neurofibromatosis type I (NF1), and/or rapidly accelerated fibrosarcoma (RAF) mutations. Patients with RAF mutations must have previously failed v-Raf murine sarcoma viral...
- Prior to enrollment, patients without an existing prior genetic test result or adequate tumor tissue sample must agree to provide tumor tissue via biopsy (paraffin section or fresh tissue specimens) that will be sent...
- Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix B).
- Patient must have an estimated life expectancy of at least 12 weeks in the opinion of the Investigator at the time of informed consent.
- Patient must have adequate organ function at screening as indicated by the following laboratory value ranges:
- Serum total bilirubin ≤ 1.5 × upper limit normal (ULN) (Serum total bilirubin can be ≤ 3.0 × ULN if patients have hemolysis or congenital hemolytic diseases)
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN or 5 × ULN for patient with liver metastases
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN or 5 × ULN for patient with liver metastases
- Albumin ≥2 mg/dL
- Creatinine clearance ≥ 45 mL/min (as calculated per Cockcroft-Gault)
- Absolute neutrophil count (ANC) ≥ 1.5×109/L
- Platelets ≥ 100×109/L
- Hemoglobin ≥ 90 g/L (Note: Criteria must be met without a transfusion within 2 weeks of obtaining the sample)
- Patient must agree to maintain abstinence (no heterosexual intercourse) or use a highly effective form of contraception during study treatment and for at least 90 days after the last dose of IP. Male patients must agree...
What rules you out
- Participation in another therapeutic clinical trial within 3 weeks of enrollment.
- Having received chemotherapy, radiotherapy, major surgery, targeted therapy, immunotherapy, or other antitumor treatment within 21 days of enrollment or five half-lives of the administered therapy, whichever occurs...
- Known or active central nervous system metastases.
- Patients with untreated brain metastases ≤ 30 mm that are asymptomatic, do not have significant edema, and do not require steroids or anti-seizure medications are eligible after discussion with the Medical Monitor.
- Patients with previously treated brain metastases may participate provided they are stable after treatment and without evidence of progression by imaging for at least 4 weeks prior to the first dose of IP administration...
- Patients with confirmed leptomeningeal disease are to be excluded.
- Unresolved toxicity from prior antitumor therapy defined as AEs \> Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for alopecia; neurotoxicity AEs of patients who have...
- Taken a medication that is a strong cytochrome P450 (CYP3A) inhibitor or inducer within 14 days of initiation of study therapy dosing.
- Taken a known corrected QT (QTc) interval prolongating medication within 7 days of initiation or longer if the half-life of the QTc prolonging medication is such that the drug is not cleared from the body within 7 days...
- Active dysphagia, digestive system disease, malabsorption syndrome, or other conditions affecting PAS-004 absorption.
- Previous or current retinal vein stenosis, retinal detachment, central retinal vein occlusion, or currently active glaucoma.
- Active interstitial pneumonia, including clinically significant radiation pneumonitis.
- Impaired cardiac function or cardiac disease as indicated by:
- Average QTc interval \> 470 ms as calculated according to the QTc formula of the instrument at the research center where electrocardiogram (ECG) measurements are performed.
- Grade ≥ 3 congestive heart failure per New York Heart Association (NYHA) guidelines.
- Clinically significant arrhythmias, including but not limited to, complete left bundle branch conduction abnormalities and 2nd degree atrioventricular block.
- Pregnant or lactating female patients.
- Known allergy or hypersensitivity to the investigational product (IP), including excipients, or history of severe adverse reaction to any drug, or sensitivity to components of the IP.
- Clinically active bacterial, fungal, or viral infections, hepatitis B (hepatitis B virus surface antigen positive and hepatitis B virus DNA over 1000 IU/ml) or hepatitis C (hepatitis C virus RNA positive), human...
The study team makes the final eligibility decision.
Where it's taking place
- Austin, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Sofia, Bulgaria
- Bucharest, Romania
- Cluj-Napoca, Romania
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austin, Texas, United States; Irving, Texas, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States; Sofia, Bulgaria; Bucharest, Romania and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.