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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: STP1002

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Denver
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STP1002	Drug: STP1002; Oral capsule, QD; Other Names: Basroparib

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Actual): March 7, 2023
• Study Completion (Actual): March 7, 2023

Study Registration Dates

• First Submitted: August 2, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 30, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: STP-ST-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No