Advanced Solid Tumor
Conditions
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.
Interventions
DRUGSTP1002
Oral capsule, QD
Sponsors
KCRN Research, LLC
ST Pharm Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| The pharmacokinetics of STP1002 | 24 months | Plasma concentration of STP1002 following oral administration |
Countries
United States
Outcome results
None listed