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

NCT04505839 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: STP-ST-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Treatment-emergent adverse events (TEAEs)

  24 months

• The pharmacokinetics of STP1002

  24 months

Study Arms (1)

STP1002

EXPERIMENTAL

Drug: STP1002

Interventions

STP1002 DRUG

Oral capsule, QD

Also known as: Basroparib

STP1002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ST Pharm Co., Ltd.: lead
• KCRN Research, LLC: collaborator

Study Sites (3)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 10, 2020
• Study Start: July 30, 2020
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

US (3)