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TerminatedPhase 1 / Phase 2NCT06016270
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedhSTC810 400 mg + Paclitaxel and hSTC810 800 mg + Paclitaxel

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 5, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?STCube, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
STCube, Inc.
Interventions being studied
Drug: hSTC810 400 mg + Paclitaxel; Drug: hSTC810 800 mg + Paclitaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Disease setting
Recurrent or relapsed→Resistant or refractory→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Tisch Cancer Institute at Mount SinaiNew York, New York
  • MD Anderson Cancer CenterHouston, Texas
  • Korea University Anam HospitalSeoul
  • Seoul National University HospitalSeoul
  • Asan Medical CenterSeoul
  • Samsung Medical CenterSeoul
  • Seoul National University Bundang HospitalSeoul
  • The Catholic University of Korea St. Vincent's HospitalSuwon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 5, 2025. Always confirm current availability with the study team.

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