A Phase 1, Multicenter, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of hSTC810 Monotherapy in Subjects With Advanced Solid Tumors

STCube, Inc.5 sites in 2 countries47 target enrollmentApril 18, 2022

ConditionsAdvanced Solid Tumor

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Solid Tumor
Sponsor: STCube, Inc.
Enrollment: 47
Locations: 5
Primary Endpoint: Incidence of DLTs
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The Purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of hSTC810 monotherapy in participants with advanced solid tumors.

Detailed Description

The study consists of a dose-escalation phase that will evaluate 6 dosing schedules of hSTC810. The first cohort will be single participant cohort. Subsequent escalation cohorts will use a standard 3+3 design, with the ability to backfill up to an additional 6 patients in each dose cohort.

Registry

clinicaltrials.gov

Start Date

April 18, 2022

End Date

February 29, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

STCube, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged at 18 ≥ years
•Capable and willing to give signed informed consent
•At least one measurable lesion as determined by RECIST Ver.1.1
•ECOG PS score ≤ 1
•Expected survival ≥ 12 weeks
•For female or male patients of reproductive potential: Agree to use contraception throughout the study and at least 6 months after the last dose.

Exclusion Criteria

•Subject who has received anti-cancer treatment within 4 weeks prior to the first dose of study treatment.
•Subject who has received radiotherapy or major surgery within 4 weeks prior to screening.
•Any toxicity due to prior therapy that has not resolved to ≤ Grade 1 or returned to baseline by the time of starting study treatment.
•Subject with known severe (≥Grade 3) hypersensitivity to any checkpoint inhibitor.
•Clinically significant laboratory abnormalities.
•Subject with a history of another invasive malignancy within 3 years before the first dose of study drug.
•Subject with active central nervous system (CNS) metastases.
•Subject who requires high dose of steroids or other immunosuppressive medications.
•Subject with a history of autoimmune disease that has required systemic treatment in the past 2 years.
•Subject with active infection that requires systemic antimicrobial treatment.