Ovarian Cancer Clinical Trial
A Study of hSTC810 With Advanced/Metastatic Solid Tumors (STCUBE-001)
The Purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of hSTC810 monotherapy in participants with advanced solid tumors.
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.
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.
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There are 5 Locations for this study
New Haven Connecticut, 06511, United States
New York New York, 10029, United States
Houston Texas, 77030, United States
Seoul , 02841, Korea, Republic of
Seoul , 03722, Korea, Republic of
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