For Healthcare Professionals

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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Ability to understand and sign an informed consent form
  2. Male or female ≥ 18 years of age
  3. Histologically or cytologically confirmed SCLC
  4. R/R ES-SCLC on or after platinum-based chemotherapy for SCLC with documented disease progression
  5. At least 1 measurable lesion as defined by RECIST 1.1
  6. Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 or 1
  7. Life expectancy of at least 3 months
  8. Adequate organ function as described in the protocol
  9. 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

Exclusion Criteria:

  1. Known active leptomeningeal disease (carcinomatous meningitis)
  2. Known active and uncontrolled central nervous system (CNS) metastases
  3. Treatment with immunotherapy, chemotherapy, targeted small molecule therapy, or any other investigational agent < 14 days prior to initiation of study treatment
  4. Treatment with radiation therapy < 14 days prior to initiation of study treatment
  5. Major surgery < 21 days prior to initiation of study treatment
  6. Received live vaccine < 30 days prior to initiation of study treatment, including intranasal influenza vaccine
  7. History of another primary malignancy with protocol-defined exceptions
  8. Active or history of autoimmune disease requiring systemic treatment
  9. Receiving high doses of steroids or other immunosuppressive medications
  10. Active hepatitis B or C infection
  11. Active or history of non-infectious pneumonitis requiring treatment with steroids
  12. Active uncontrolled viral, fungal, or bacterial infection including tuberculosis
  13. Pregnant or breastfeeding female patients
  14. History of severe hypersensitivity reaction to a monoclonal antibody treatment
  15. History of severe hypersensitivity reaction or ≥ Grade 3 adverse event (AE) to paclitaxel treatment
  16. History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to screening
  17. QT Corrected for Fridericia's method (QTcF) > 470 ms at screening
  18. Lack of resolution of any toxicity to max Grade 1 (except alopecia)
  19. Active or history of any condition, therapy, or lab abnormality that may interfere with the patient participation for the full duration of the study
  20. Known psychiatric or substance use disorder
  21. Positive Coronavirus disease 2019 (COVID-19) test at screening
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 82-2-551-3370Email iconEmail Study Center

Study Details


Contition

Extensive Stage Small Cell Lung Cancer

Age

18+

Phase

PHASE1/PHASE2

Participants Needed

130

Est. Completion Date

Oct 31, 2027

Treatment Type

INTERVENTIONAL


Sponsor

STCube, Inc.

ClinicalTrials.gov NCT Identifier

NCT06016270

Study Number

STCUBE-002

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