A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer

August 28, 2025 updated by: STCube, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Suwon, South Korea, 16247
        • The Catholic University Of Korea St. Vincent's Hospital
  • United States
    • New York
      • New York, New York, United States, 10029
        • Tisch Cancer Institute at Mount Sinai
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: hSTC810 400 mg + Paclitaxel
hSTC810 400 mg will be administered with a standard dose of paclitaxel
Drug: hSTC810 400 mg + Paclitaxel

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
Experimental: hSTC810 800 mg + Paclitaxel
hSTC810 800 mg will be administered with a standard dose of paclitaxel
Drug: hSTC810 800 mg + Paclitaxel
hSTC810 800 mg and paclitaxel 175 mg/m2 will be administered as an IV infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months
Progression Free Survival (PFS) rate
Time Frame: 6 months
Proportion of patients without documented progression of disease and alive at 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: Up to 4 years
Incidence, causality, and nature of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Up to 4 years
Overall Response Rate (ORR)
Time Frame: Up to 4 years
Investigator assessed ORR defined by RECIST 1.1
Up to 4 years
Duration of Response (DoR)
Time Frame: Up to 4 years
Time from the date of first documented CR or PR until the date of documented progression or death
Up to 4 years
Progression Free Survival (PFS)
Time Frame: Up to 4 years
Time from first dose until the date of objective disease progression or death
Up to 4 years
Clinical Benefit Rate (CBR)
Time Frame: Up to 4 years
Percentage of evaluable patients with CR, PR, or Stable Disease (SD) lasting ≥ 24 weeks
Up to 4 years
Overall Survival (OS)
Time Frame: Up to 4 years
Time from first dose of study drug until the date of death
Up to 4 years
Overall Survival (OS) rate
Time Frame: 12 months
Proportion of patients alive at 12 months after the first dose of study drug
12 months
Maximum plasma concentration (Cmax)
Time Frame: Up to 21 days
Maximum plasma concentration of hSTC810 to evaluate PK parameters
Up to 21 days
Area under the concentration-time curve from 0 to 21 days (AUC0-21)
Time Frame: Up to 21 days
AUC from 0 to 21 days to evaluate PK parameters
Up to 21 days
Area under the concentration-time curve extrapolated from 0 to infinity (AUCo-inf)
Time Frame: Up to 21 days
AUC from time 0 to infinity to evaluate total drug exposure over time
Up to 21 days
Incidence of anti-drug antibodies (ADA)
Time Frame: Up to 4 years
Number and percentage of patients with positive ADAs
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
STCube, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STCUBE-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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