Advanced Solid TumorPhase 1NCT05231746
A Study of hSTC810 With Advanced/Metastatic Solid Tumors (STCUBE-001)
A Phase 1 study testing hSTC810 in people with Advanced Solid Tumor, run by STCube, Inc. at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- hSTC810
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 18 Apr 2022to 29 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Yale Cancer Center
New Haven, Connecticut, 06511
Mount Sinai Hospital
New York, New York, 10029
South Korea2 sites
Korea University Anam Hospital
Seoul, 02841
Yonsei University Severance Hospital
Seoul, 03722
About this study
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
The Purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of hSTC810 monotherapy in participants with advanced solid tumors.
Read the 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- hSTC810
- 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
- Medical subject headings
- Colorectal Neoplasms, Head and Neck Neoplasms, Ovarian Neoplasms, Urinary Bladder Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hSTC810Biological
hSTC810 will be administered as an intravenous infusion (IV)
| Study group | Role | What they receive |
|---|---|---|
| hSTC810 | Experimental | 6 escalating doses of hSTC810 will be administered to participants Receives: Biological: hSTC810 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLTs
Number and percentages of subjects with DLTs
Measured: 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
Measured: from signing ICF to 90 days after last dose
Secondary outcomes (11)
Peak plasma concentration (Cmax)
Maximum plasma concentration of hSTC810 to evaluate the PK parameters
Measured: Up to 2 years
Minimum plasma concentration (Cmin)
Minimum blood plasma concentration of hSTC810 to evaluate the PK parameters
Measured: Up to 2 years
Time to maximum plasma concentration (Tmax)
Time to reach Cmax of hSTC810 to evaluate the PK parameters.
Measured: 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
Measured: Up to 2 years
Incidence of ADA
Number and percentages of subjects with positive ADAs
Measured: Up to 2 years
Objective response rate (ORR)
Percentage of participants with confirmed CR and confirmed PR determined by RECIST v1.1 and iRECIST
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 2 years
Overall survival (OS)
The period from first dose to the day of death from any cause.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start18 Apr 2022
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- STCube, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical director, Study director, STCube, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231746
- Sponsor's protocol ID
- STCUBE-001
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05231746
- Acronym / sponsor ID
- STCUBE-001
- Conditions
- Advanced Solid Tumor
- Keywords
- Immune Checkpoint Inhibitors, Antineoplastic Agents, Therapeutic Uses, Colorectal Neoplasms, Head and Neck Neoplasms, Ovarian Neoplasms, Urinary Bladder Neoplasms, Lung Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- STCube, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hSTC810 | Experimental | Biological: hSTC8106 escalating doses of hSTC810 will be administered to participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hSTC810hSTC810 will be administered as an intravenous infusion (IV) | Biological | hSTC810 |
Primary outcome
Incidence of DLTs
Time frame: 4 weeks
Number and percentages of subjects with DLTs
Incidence of AEs, SAEs, and abnormalities in Lab
Time frame: from signing ICF to 90 days after last dose
Number and percentages of subjects with Adverse Event, serious AEs, and abnormalities in lab parameters
11 secondary outcomes
Peak plasma concentration (Cmax)
Time frame: Up to 2 years
Minimum plasma concentration (Cmin)
Time frame: Up to 2 years
Time to maximum plasma concentration (Tmax)
Time frame: Up to 2 years
Area under the plasma concentration - time curve (AUC0-t)
Time frame: Up to 2 years
Incidence of ADA
Time frame: Up to 2 years
Objective response rate (ORR)
Time frame: Up to 2 years
Best overall response (BOR)
Time frame: Up to 2 years
Clinical Benefit rate (CBR)
Time frame: Up to 2 years
Duration of response (DoR)
Time frame: Up to 2 years
Progression free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical director study director
STCube, Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hSTC810 in people with Advanced Solid Tumor, run by STCube, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLTs (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.