Status:
COMPLETED
First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors
Lead Sponsor:
ST Pharm Co., Ltd.
Collaborating Sponsors:
KCRN Research, LLC
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04505839
Start Date
July 30 2020
End Date
March 7 2023
Last Update
July 3 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Southern California
Los Angeles, California, United States, 90033
2
University of Colorado Denver
Denver, Colorado, United States, 80045
3
Northwestern University
Evanston, Illinois, United States, 60208