A Study of hSTC810 With Advanced/Metastatic Solid Tumors (STCUBE-001)
Study Phase: Phase 1
Recruitment Status: Recruiting
Start Date: April 01, 2022
End Date: August 01, 2024
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.
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Conditions:
- Neoplasms