First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors
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This is an open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) and to determine the maximum tolerated dose (MTD) of STP1002 in patients with advanced-stage solid tumors.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Advanced-stage solid tumor (metastatic or locally advanced and unresectable) with histologically confirmed diagnosis of CRC, NSCLC, GC, RCC, or HCC
Measurable lesion(s) according to RECIST 1.1 criteria
Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
Ability to swallow capsules
Received last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to first dosing of study treatment
Has received or is intolerant to all standard of care treatment options with known clinical benefit
Life expectancy of more than 3 months
Adequate hematological, hepatic and renal function
For women of childbearing potential, a negative serum pregnancy test performed within 7 days prior to start of treatment
Received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry
Major surgery within the last 28 days prior to the first dose of investigational drug
Prior radiation therapy within 14 days prior to study Cycle 1 Day 1 and/or persistence of radiation-related adverse effects.
Concurrent treatment with any anticancer agent
Currently taking either strong CYP inhibitors or inducers
Known brain metastases, uncontrolled seizure disorder, or active neurologic disease
Significant cardiovascular impairment
Pregnant or nursing
Known HIV infection, active hepatitis C and/or hepatitis B infection
Known bleeding disorder or coagulopathy
Active drug or alcohol abuse or history of alcohol or drug abuse during the last two years.
Diagnosis of osteoporosis at the time of the screening
Any history of retinal pathology including diabetic retinopathy, macular degeneration, or other retinal degenerative disease