A Study of hSTC810 With Advanced/Metastatic Solid Tumors (STCUBE-001)
- Conditions
- Advanced Solid Tumor
- Interventions
- Biological: hSTC810
- Registration Number
- NCT05231746
- Lead Sponsor
- STCube, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description hSTC810 hSTC810 6 escalating doses of hSTC810 will be administered to participants
- Primary Outcome Measures
Name Time Method Incidence of DLTs 4 weeks Number and percentages of subjects with DLTs
Incidence of AEs, SAEs, and abnormalities in Lab from signing ICF to 90 days after last dose Number and percentages of subjects with Adverse Event, serious AEs, and abnormalities in lab parameters
- Secondary Outcome Measures
Name Time Method Peak plasma concentration (Cmax) Up to 2 years Maximum plasma concentration of hSTC810 to evaluate the PK parameters
Minimum plasma concentration (Cmin) Up to 2 years Minimum blood plasma concentration of hSTC810 to evaluate the PK parameters
Progression free survival (PFS) Up to 2 years The period from the first dose to the documented disease progression or death determined by RECIST v1.1 or iRECIST
Time to maximum plasma concentration (Tmax) Up to 2 years Time to reach Cmax of hSTC810 to evaluate the PK parameters.
Incidence of ADA Up to 2 years Number and percentages of subjects with positive ADAs
Objective response rate (ORR) Up to 2 years Percentage of participants with confirmed CR and confirmed PR determined by RECIST v1.1 and iRECIST
Best overall response (BOR) Up to 2 years the best response designation as determined by RECIST and iRECIST. The BOR will be categorized as a CR, PR, SD, or PD
Clinical Benefit rate (CBR) Up to 2 years 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
Area under the plasma concentration - time curve (AUC0-t) Up to 2 years AUC up to the last measurable concentration of hSTC810 to evaluate the PK parameters
Overall survival (OS) Up to 2 years The period from first dose to the day of death from any cause.
Duration of response (DoR) Up to 2 years Time from initial response of confirmed CR or PR to disease progression or death determined by RECIST v1.1 and iRECIST
Trial Locations
- Locations (5)
Yonsei University Severance Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Mount Sinai Hospital
🇺🇸New York, New York, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States