Description:
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.
Title
- Brief Title: First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors
- Official Title: First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
STP-ST-01
- NCT ID:
NCT04505839
Conditions
Interventions
Drug | Synonyms | Arms |
---|
STP1002 | | STP1002 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
STP1002 | Experimental | | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose limiting toxicities (DLTs) |
Time Frame: | 28 days |
Safety Issue: | |
Description: | 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
Measure: | Treatment-emergent adverse events (TEAEs) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Number and severity of TEAEs, treatment-related AEs, and SAEs for all dose groups according to the NCI CTCAE v5.0 |
Measure: | The pharmacokinetics of STP1002 |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Plasma concentration of STP1002 following oral administration |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | ST Pharm Co., Ltd. |
Last Updated
December 16, 2020