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

ID#: NCT05231746

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: April 01, 2022

End Date: August 01, 2024

Contact Information:
Yujin Jung
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.

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.