Clinical trial NCT04505839: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: ST Pharm Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: KCRN Research, LLC
First posted: 2020-08-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Dose limiting toxicities (DLTs)
timeFrame: 28 days
Secondary outcomes:
measure: Treatment-emergent adverse events (TEAEs)
timeFrame: 24 months
measure: The pharmacokinetics of STP1002
timeFrame: 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: