A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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 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.
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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