First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors
- Registration Number
- NCT04505839
- Lead Sponsor
- ST Pharm Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description STP1002 STP1002 -
- Primary Outcome Measures
Name Time Method Dose limiting toxicities (DLTs) 28 days DLTs are defined as any of the following adverse events (AEs) that are possibly or probably related to the trial regimen occurring during Cycle 1
- Secondary Outcome Measures
Name Time Method The pharmacokinetics of STP1002 24 months Plasma concentration of STP1002 following oral administration
Treatment-emergent adverse events (TEAEs) 24 months Number and severity of TEAEs, treatment-related AEs, and SAEs for all dose groups according to the NCI CTCAE v5.0
Trial Locations
- Locations (3)
University of Southern California
🇺🇸Los Angeles, California, United States
University of Colorado Denver
🇺🇸Denver, Colorado, United States
Northwestern University
🇺🇸Evanston, Illinois, United States