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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05231746
• Other study ID #: STCUBE-001
• Status: Completed
• Phase: Phase 1
• Start date: April 18, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: February 2023
• Source: STCube, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Biological:
• hSTC810
hSTC810 will be administered as an intravenous infusion (IV)

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
United States	MD Anderson Cancer Center	Houston	Texas
United States	Yale Cancer Center	New Haven	Connecticut
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
STCube, Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of DLTs	Number and percentages of subjects with DLTs	4 weeks
Primary	Incidence of AEs, SAEs, and abnormalities in Lab	Number and percentages of subjects with Adverse Event, serious AEs, and abnormalities in lab parameters	from signing ICF to 90 days after last dose
Secondary	Peak plasma concentration (Cmax)	Maximum plasma concentration of hSTC810 to evaluate the PK parameters	Up to 2 years
Secondary	Minimum plasma concentration (Cmin)	Minimum blood plasma concentration of hSTC810 to evaluate the PK parameters	Up to 2 years
Secondary	Time to maximum plasma concentration (Tmax)	Time to reach Cmax of hSTC810 to evaluate the PK parameters.	Up to 2 years
Secondary	Area under the plasma concentration - time curve (AUC0-t)	AUC up to the last measurable concentration of hSTC810 to evaluate the PK parameters	Up to 2 years
Secondary	Incidence of ADA	Number and percentages of subjects with positive ADAs	Up to 2 years
Secondary	Objective response rate (ORR)	Percentage of participants with confirmed CR and confirmed PR determined by RECIST v1.1 and iRECIST	Up to 2 years
Secondary	Best overall response (BOR)	the best response designation as determined by RECIST and iRECIST. The BOR will be categorized as a CR, PR, SD, or PD	Up to 2 years
Secondary	Clinical Benefit rate (CBR)	Percentage of Participants With confirmed CR, confirmed PR or SD with a duration of at least 6 months determined by RECIST v1.1 and iRECIST	Up to 2 years
Secondary	Duration of response (DoR)	Time from initial response of confirmed CR or PR to disease progression or death determined by RECIST v1.1 and iRECIST	Up to 2 years
Secondary	Progression free survival (PFS)	The period from the first dose to the documented disease progression or death determined by RECIST v1.1 or iRECIST	Up to 2 years
Secondary	Overall survival (OS)	The period from first dose to the day of death from any cause.	Up to 2 years