Status:
COMPLETED
A Study of hSTC810 With Advanced/Metastatic Solid Tumors (STCUBE-001)
Lead Sponsor:
STCube, Inc.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
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+...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT05231746
Start Date
April 18 2022
End Date
February 29 2024
Last Update
March 13 2024
Active Locations (5)
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1
Yale Cancer Center
New Haven, Connecticut, United States, 06511
2
Mount Sinai Hospital
New York, New York, United States, 10029
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
Korea University Anam Hospital
Seoul, South Korea, 02841