First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors

Study Overview
=================
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.

Official Title
-----------------
First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors

Conditions
-----------------
Advanced Solid Tumor

Intervention / Treatment
-----------------
* Drug: STP1002


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STP1002<br> | Drug: STP1002<br>* Oral capsule, QD<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicities (DLTs) | 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 | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent adverse events (TEAEs) | Number and severity of TEAEs, treatment-related AEs, and SAEs for all dose groups according to the NCI CTCAE v5.0 | 24 months | 
| The pharmacokinetics of STP1002 | Plasma concentration of STP1002 following oral administration | 24 months |