A Study of hSTC810 With Advanced/Metastatic Solid Tumors (STCUBE-001)

NCT ID: NCT05231746

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2024-02-29

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.

Conditions

Advanced Solid Tumor

Study Design

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

Study Groups

hSTC810

6 escalating doses of hSTC810 will be administered to participants

Group Type: EXPERIMENTAL

hSTC810

Intervention Type: BIOLOGICAL

hSTC810 will be administered as an intravenous infusion (IV)

Interventions

hSTC810

hSTC810 will be administered as an intravenous infusion (IV)

Intervention Type: BIOLOGICAL

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.
• Subject with active HBV or HCV infection.
• Subject who has a known history of HIV infection.
• Subject with active tuberculosis.
• Subject with a documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class IV within 6 months prior to screening.
• Subject with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening CT scan.
• Subject who has received a prior allogeneic stem cell or solid organ transplant.
• Subject with a positive coronavirus disease (COVID) test during screening.
• Subjects who have received a live attenuated vaccine within 30 days prior to screening.
• Subject with another underlying medical condition.

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

Sponsors

STCube, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical director

Role: STUDY_DIRECTOR

STCube, Inc.

Locations

Yale Cancer Center

New Haven, Connecticut, United States

Mount Sinai Hospital

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

Korea University Anam Hospital

Seoul, , South Korea

Yonsei University Severance Hospital

Seoul, , South Korea

Countries

United States; South Korea

Other Identifiers

STCUBE-001

Identifier Type: -

Identifier Source: org_study_id