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.

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.

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.