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

Study Overview
=================
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.

Official Title
-----------------
A Phase 1, Multicenter, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of hSTC810 Monotherapy in Subjects With Advanced Solid Tumors

Conditions
-----------------
Advanced Solid Tumor

Intervention / Treatment
-----------------
* Biological: hSTC810


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hSTC810<br>6 escalating doses of hSTC810 will be administered to participants | Biological: hSTC810<br>* hSTC810 will be administered as an intravenous infusion (IV)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urinary Bladder Neoplasms, Immune Checkpoint Inhibitors, Antineoplastic Agents, Therapeutic Uses, Colorectal Neoplasms, Head and Neck Neoplasms, Ovarian Neoplasms, Lung Neoplasms, Antibodies, Monoclonal, anti-BTN1A1, butyrophilins