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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ST Pharm Co., Ltd.
• Collaborator: KCRN Research, LLC

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