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

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Biological: hSTC810

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 03722
    • Yonsei University Severance Hospital
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale Cancer Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hSTC810; 6 escalating doses of hSTC810 will be administered to participants	Biological: hSTC810; hSTC810 will be administered as an intravenous infusion (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of DLTs	Number and percentages of subjects with DLTs	4 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration (Cmax)	Maximum plasma concentration of hSTC810 to evaluate the PK parameters	Up to 2 years
Minimum plasma concentration (Cmin)	Minimum blood plasma concentration of hSTC810 to evaluate the PK parameters	Up to 2 years
Time to maximum plasma concentration (Tmax)	Time to reach Cmax of hSTC810 to evaluate the PK parameters.	Up to 2 years
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
Incidence of ADA	Number and percentages of subjects with positive ADAs	Up to 2 years
Objective response rate (ORR)	Percentage of participants with confirmed CR and confirmed PR determined by RECIST v1.1 and iRECIST	Up to 2 years
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
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
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
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
Overall survival (OS)	The period from first dose to the day of death from any cause.	Up to 2 years

Collaborators and Investigators

• Sponsor: STCube, Inc.
• Investigators: Study Director: Medical director, STCube, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Urinary Bladder Neoplasms; Ovarian Neoplasms; Immune Checkpoint Inhibitors; Antineoplastic Agents; Antibodies, Monoclonal; Colorectal Neoplasms; Head and Neck Neoplasms; Therapeutic Uses; Lung Neoplasms; anti-BTN1A1; butyrophilins
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: STCUBE-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No