Extensive Stage Small Cell Lung CancerPhase 1/2NCT06016270
A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer
A Phase 1/2 study testing hSTC810 400 mg + Paclitaxel and hSTC810 800 mg + Paclitaxel in people with Extensive Stage Small Cell Lung Cancer, run by STCube, Inc. at 8 sites in 2 countries.
Trial summary
The purpose of this clinical study is to assess the safety and efficacy of hSTC810 and paclitaxel combination therapy in patients with relapsed or refractory extensive stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- hSTC810 400 mg + Paclitaxel and hSTC810 800 mg + Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 13 Feb 2024to 25 Aug 2025
- Phase
- Phase 1/2
- 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
- Ability to understand and sign an informed consent form
- Male or female ≥ 18 years of age
- Histologically or cytologically confirmed SCLC
- R/R ES-SCLC on or after platinum-based chemotherapy for SCLC with documented disease progression
- At least 1 measurable lesion as defined by RECIST 1.1
- Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 or 1
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- Life expectancy of at least 3 months
- Adequate organ function as described in the protocol
- For female or male patients with reproductive potential: Agree to use contraception throughout the study and at least 5 months after the last dose.
Who cannot join
- Known active leptomeningeal disease (carcinomatous meningitis)
- Known active and uncontrolled central nervous system (CNS) metastases
- Treatment with immunotherapy, chemotherapy, targeted small molecule therapy, or any other investigational agent < 14 days prior to initiation of study treatment
- Treatment with radiation therapy < 14 days prior to initiation of study treatment
- Major surgery < 21 days prior to initiation of study treatment
- Received live vaccine < 30 days prior to initiation of study treatment, including intranasal influenza vaccine
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- History of another primary malignancy with protocol-defined exceptions
- Active or history of autoimmune disease requiring systemic treatment
- Receiving high doses of steroids or other immunosuppressive medications
- Active hepatitis B or C infection
- Active or history of non-infectious pneumonitis requiring treatment with steroids
- Active uncontrolled viral, fungal, or bacterial infection including tuberculosis
- Pregnant or breastfeeding female patients
- History of severe hypersensitivity reaction to a monoclonal antibody treatment
- History of severe hypersensitivity reaction or ≥ Grade 3 adverse event (AE) to paclitaxel treatment
- History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to screening
- QT Corrected for Fridericia's method (QTcF) > 470 ms at screening
- Lack of resolution of any toxicity to max Grade 1 (except alopecia)
- Active or history of any condition, therapy, or lab abnormality that may interfere with the patient participation for the full duration of the study
- Known psychiatric or substance use disorder
- Positive Coronavirus disease 2019 (COVID-19) test at screening
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
South Korea6 sites
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Seoul National University Bundang Hospital
Seoul, 13620
The Catholic University of Korea St. Vincent's Hospital
Suwon, 16247
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Tisch Cancer Institute at Mount Sinai
New York, New York, 10029
About this study
Official title: A Phase Ib/II Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer
The purpose of this clinical study is to assess the safety and efficacy of hSTC810 and paclitaxel combination therapy in patients with relapsed or refractory extensive stage small cell lung cancer.
Read the detailed description
The study will be conducted in 2 parts. Phase Ib will evaluate the safety of the combination of hSTC810 with a standard dose of paclitaxel using a 3+3 dose escalation design. Phase II will evaluate the efficacy of hSTC810 + paclitaxel combination therapy using a Simon 2-stage method.
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- hSTC810 400 mg + Paclitaxel, hSTC810 800 mg + Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hSTC810 400 mg + PaclitaxelDrug
hSTC810 400 mg and paclitaxel 175 mg/m2 will be administered as an intravenous (IV) infusion
Paclitaxel: 175 mg/m2 will be administered as an IV infusion
hSTC810 800 mg + PaclitaxelDrug
hSTC810 800 mg and paclitaxel 175 mg/m2 will be administered as an IV infusion
| Study group | Role | What they receive |
|---|---|---|
| hSTC810 400 mg + Paclitaxel | Experimental | hSTC810 400 mg will be administered with a standard dose of paclitaxel Receives: Drug: hSTC810 400 mg + Paclitaxel |
| hSTC810 800 mg + Paclitaxel | Experimental | hSTC810 800 mg will be administered with a standard dose of paclitaxel Receives: Drug: hSTC810 800 mg + Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Percentage of patients with confirmed Confirmed Response (CR) or Partial Response (PR) as defined by RECIST 1.1 at 3 months
Measured: 3 months
Progression Free Survival (PFS) rate
Proportion of patients without documented progression of disease and alive at 6 months
Measured: 6 months
Secondary outcomes (11)
Safety and tolerability
Incidence, causality, and nature of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to 4 years
Overall Response Rate (ORR)
Investigator assessed ORR defined by RECIST 1.1
Measured: Up to 4 years
Duration of Response (DoR)
Time from the date of first documented CR or PR until the date of documented progression or death
Measured: Up to 4 years
Progression Free Survival (PFS)
Time from first dose until the date of objective disease progression or death
Measured: Up to 4 years
Clinical Benefit Rate (CBR)
Percentage of evaluable patients with CR, PR, or Stable Disease (SD) lasting ≥ 24 weeks
Measured: Up to 4 years
Overall Survival (OS)
Time from first dose of study drug until the date of death
Measured: Up to 4 years
Overall Survival (OS) rate
Proportion of patients alive at 12 months after the first dose of study drug
Measured: 12 months
Maximum plasma concentration (Cmax)
Maximum plasma concentration of hSTC810 to evaluate PK parameters
Measured: Up to 21 days
Area under the concentration-time curve from 0 to 21 days (AUC0-21)
AUC from 0 to 21 days to evaluate PK parameters
Measured: Up to 21 days
Area under the concentration-time curve extrapolated from 0 to infinity (AUCo-inf)
AUC from time 0 to infinity to evaluate total drug exposure over time
Measured: Up to 21 days
Incidence of anti-drug antibodies (ADA)
Number and percentage of patients with positive ADAs
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start13 Feb 2024
- Primary completion23 Jan 2025
- Study completion25 Aug 2025
Why it stopped: Company strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Small Cell Lung CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- STCube, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016270
- Sponsor's protocol ID
- STCUBE-002
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 5 Sep 2025
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06016270
- Acronym / sponsor ID
- STCUBE-002
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company strategy
- Enrolment
- 10 participants (actual)
- Lead sponsor
- STCube, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 29 Aug 2023 (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 clinical study is to assess the safety and efficacy of hSTC810 and paclitaxel combination therapy in patients with relapsed or refractory extensive stage small cell lung cancer.
Detailed description
The study will be conducted in 2 parts. Phase Ib will evaluate the safety of the combination of hSTC810 with a standard dose of paclitaxel using a 3+3 dose escalation design. Phase II will evaluate the efficacy of hSTC810 + paclitaxel combination therapy using a Simon 2-stage method.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hSTC810 400 mg + Paclitaxel | Experimental | Drug: hSTC810 400 mg + PaclitaxelhSTC810 400 mg will be administered with a standard dose of paclitaxel |
| hSTC810 800 mg + Paclitaxel | Experimental | Drug: hSTC810 800 mg + PaclitaxelhSTC810 800 mg will be administered with a standard dose of paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to understand and sign an informed consent form
- Male or female ≥ 18 years of age
- Histologically or cytologically confirmed SCLC
- R/R ES-SCLC on or after platinum-based chemotherapy for SCLC with documented disease progression
- At least 1 measurable lesion as defined by RECIST 1.1
Key exclusion criteria (21 listed)
- Known active leptomeningeal disease (carcinomatous meningitis)
- Known active and uncontrolled central nervous system (CNS) metastases
- Treatment with immunotherapy, chemotherapy, targeted small molecule therapy, or any other investigational agent < 14 days prior to initiation of study treatment
- Treatment with radiation therapy < 14 days prior to initiation of study treatment
- Major surgery < 21 days prior to initiation of study treatment
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 |
|---|---|---|
| hSTC810 400 mg + PaclitaxelhSTC810 400 mg and paclitaxel 175 mg/m2 will be administered as an intravenous (IV) infusion Paclitaxel: 175 mg/m2 will be administered as an IV infusion | Drug | hSTC810 400 mg + Paclitaxel |
| hSTC810 800 mg + PaclitaxelhSTC810 800 mg and paclitaxel 175 mg/m2 will be administered as an IV infusion | Drug | hSTC810 800 mg + Paclitaxel |
Primary outcome
Overall Response Rate (ORR)
Time frame: 3 months
Percentage of patients with confirmed Confirmed Response (CR) or Partial Response (PR) as defined by RECIST 1.1 at 3 months
Progression Free Survival (PFS) rate
Time frame: 6 months
Proportion of patients without documented progression of disease and alive at 6 months
11 secondary outcomes
Safety and tolerability
Time frame: Up to 4 years
Overall Response Rate (ORR)
Time frame: Up to 4 years
Duration of Response (DoR)
Time frame: Up to 4 years
Progression Free Survival (PFS)
Time frame: Up to 4 years
Clinical Benefit Rate (CBR)
Time frame: Up to 4 years
Overall Survival (OS)
Time frame: Up to 4 years
Overall Survival (OS) rate
Time frame: 12 months
Maximum plasma concentration (Cmax)
Time frame: Up to 21 days
Area under the concentration-time curve from 0 to 21 days (AUC0-21)
Time frame: Up to 21 days
Area under the concentration-time curve extrapolated from 0 to infinity (AUCo-inf)
Time frame: Up to 21 days
Incidence of anti-drug antibodies (ADA)
Time frame: Up to 4 years
Results and safety
The study was stopped early (reason given: Company strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing hSTC810 400 mg + Paclitaxel and hSTC810 800 mg + Paclitaxel in people with Extensive Stage Small Cell Lung Cancer, run by STCube, Inc. at 8 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 9 inclusion and 21 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: stopped early, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea, United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Company strategy). Results are not available in the source record.
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?
Overall Response Rate (ORR) (time frame: 3 months). 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 5 Sep 2025.