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The Purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of hSTC810 monotherapy in participants with advanced solid tumors.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hSTC810 | Experimental | 6 escalating doses of hSTC810 will be administered to participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hSTC810 | Biological | hSTC810 will be administered as an intravenous infusion (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of DLTs | Number and percentages of subjects with DLTs | 4 weeks |
| Incidence of AEs, SAEs, and abnormalities in Lab | Number and percentages of subjects with Adverse Event, serious AEs, and abnormalities in lab parameters | from signing ICF to 90 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) | Maximum plasma concentration of hSTC810 to evaluate the PK parameters | Up to 2 years |
| Minimum plasma concentration (Cmin) | Minimum blood plasma concentration of hSTC810 to evaluate the PK parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical director | STCube, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06511 | United States | ||
| Mount Sinai Hospital |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D010051 | Ovarian Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Up to 2 years |
| Time to maximum plasma concentration (Tmax) | Time to reach Cmax of hSTC810 to evaluate the PK parameters. | Up to 2 years |
| Area under the plasma concentration - time curve (AUC0-t) | AUC up to the last measurable concentration of hSTC810 to evaluate the PK parameters | Up to 2 years |
| Incidence of ADA | Number and percentages of subjects with positive ADAs | Up to 2 years |
| Objective response rate (ORR) | Percentage of participants with confirmed CR and confirmed PR determined by RECIST v1.1 and iRECIST | Up to 2 years |
| Best overall response (BOR) | the best response designation as determined by RECIST and iRECIST. The BOR will be categorized as a CR, PR, SD, or PD | Up to 2 years |
| Clinical Benefit rate (CBR) | 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 | Up to 2 years |
| Duration of response (DoR) | Time from initial response of confirmed CR or PR to disease progression or death determined by RECIST v1.1 and iRECIST | Up to 2 years |
| Progression free survival (PFS) | The period from the first dose to the documented disease progression or death determined by RECIST v1.1 or iRECIST | Up to 2 years |
| Overall survival (OS) | The period from first dose to the day of death from any cause. | Up to 2 years |
| New York |
| New York |
| 10029 |
| United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Yonsei University Severance Hospital | Seoul | 03722 | South Korea |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014571 | Urologic Neoplasms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |