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

NCT ID: NCT04505839

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-30
• Study Completion Date: 2023-03-07

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STP1002

Group Type: EXPERIMENTAL

STP1002

Intervention Type: DRUG

Oral capsule, QD

Interventions

STP1002

Oral capsule, QD

Intervention Type: DRUG

Other Intervention Names

Basroparib

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCRN Research, LLC

INDUSTRY

Sponsor Role: collaborator

ST Pharm Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Southern California

Los Angeles, California, United States

University of Colorado Denver

Denver, Colorado, United States

Northwestern University

Evanston, Illinois, United States

Countries

United States

Other Identifiers

STP-ST-01

Identifier Type: -

Identifier Source: org_study_id