Advanced Solid Tumor
Conditions
Keywords
Immune Checkpoint Inhibitors, Antineoplastic Agents, Therapeutic Uses, Colorectal Neoplasms, Head and Neck Neoplasms, Ovarian Neoplasms, Urinary Bladder Neoplasms, Lung Neoplasms, Antibodies, Monoclonal, anti-BTN1A1, butyrophilins
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+3 design, with the ability to backfill up to an additional 6 patients in each dose cohort.
Interventions
BIOLOGICALhSTC810
hSTC810 will be administered as an intravenous infusion (IV)
Sponsors
STCube, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of DLTs | 4 weeks | Number and percentages of subjects with DLTs |
| Incidence of AEs, SAEs, and abnormalities in Lab | from signing ICF to 90 days after last dose | Number and percentages of subjects with Adverse Event, serious AEs, and abnormalities in lab parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to maximum plasma concentration (Tmax) | Up to 2 years | Time to reach Cmax of hSTC810 to evaluate the PK parameters. |
| Area under the plasma concentration - time curve (AUC0-t) | Up to 2 years | AUC up to the last measurable concentration of hSTC810 to evaluate the PK parameters |
| Incidence of ADA | Up to 2 years | Number and percentages of subjects with positive ADAs |
| Objective response rate (ORR) | Up to 2 years | Percentage of participants with confirmed CR and confirmed PR determined by RECIST v1.1 and iRECIST |
| Peak plasma concentration (Cmax) | Up to 2 years | Maximum plasma concentration of hSTC810 to evaluate the PK parameters |
| Clinical Benefit rate (CBR) | Up to 2 years | Percentage of Participants With confirmed CR, confirmed PR or SD with a duration of at least 6 months determined by RECIST v1.1 and iRECIST |
| Duration of response (DoR) | Up to 2 years | Time from initial response of confirmed CR or PR to disease progression or death determined by RECIST v1.1 and iRECIST |
| Progression free survival (PFS) | Up to 2 years | The period from the first dose to the documented disease progression or death determined by RECIST v1.1 or iRECIST |
| Overall survival (OS) | Up to 2 years | The period from first dose to the day of death from any cause. |
| Best overall response (BOR) | Up to 2 years | the best response designation as determined by RECIST and iRECIST. The BOR will be categorized as a CR, PR, SD, or PD |
| Minimum plasma concentration (Cmin) | Up to 2 years | Minimum blood plasma concentration of hSTC810 to evaluate the PK parameters |
Countries
South Korea, United States
Outcome results
None listed