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

ST Pharma

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: STP1002

Study type: Interventional

Funder types: Industry

Identifiers

NCT04505839

STP-ST-01

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

STP1002

Experimental group

Treatment:

Drug: STP1002