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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 13, 2024 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- STCube, Inc.
- Interventions being studied
- Biological: hSTC810
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Yale Cancer CenterNew Haven, Connecticut
- Mount Sinai HospitalNew York, New York
- MD Anderson Cancer CenterHouston, Texas
- Korea University Anam HospitalSeoul
- Yonsei University Severance HospitalSeoul
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 13, 2024. Always confirm current availability with the study team.