PAS-004 in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPasithea Therapeutics Corp.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 given written consent to participation in the study prior to study start and any study-related procedure.
Patient must be at least 18 years of age at the time of signing the ICF.
Patient must be able to swallow oral medication.
Disqualifiers
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 first.
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.
Trial design
Design model
Sequential
Treatments tested in this trial
PAS-004 Capsules
DrugA mitogen-activated protein kinase/extracellular signal-regulated kinase kinase (MAPK/ERK kinase, or MEK) 1/2 inhibitor presented in 1 mg, 4mg, and 10 mg strength capsules, intended for oral administration once daily.
PAS-004 Tablets
DrugA mitogen-activated protein kinase/extracellular signal-regulated kinase kinase (MAPK/ERK kinase, or MEK) 1/2 inhibitor presented in 4mg strength tablets, intended for oral administration once daily.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: PAS-004 CapsulesExperimental treatment 1 intervention
Group B: PAS-004 TabletsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of dose limiting toxicities (DLTs)
Pre-defined DLTs will be assessed for dose escalation and expansion determinations.
Time frame
Day 1 through Day 35 (Cycle 1)2
Evaluation of adverse events (AEs)
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).
Time frame
Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug3
Evaluation of AEs leading to discontinuation of investigational product (IP), PAS-004.
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).
Time frame
Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug4
Evaluation of hematology laboratory parameters
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).
Time frame
Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drugSecondary outcomes
1
Apparent terminal elimination half-life (t1/2) in Plasma
Time frame
Cycle 1: Day 1 and Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4, 8, 15, 29 and 35 (predose)2
Peak Plasma Concentration (Cmax)
Time frame
Cycle 1: Day 1 and Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4, 8, 15, 29 and 35 (predose)3
Plasma predose or trough concentration (Ctau/Ctrough)
Time frame
Cycle 1: Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 8, 15, 29 and 35 (predose)4
Time of maximum plasma concentration (Tmax)
Time frame
Cycle 1: Day 1 and Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4, 8, 15, 29 and 35 (predose)Sponsors and contacts
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Source ClinicalTrials.gov