A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer
Reason given: Company strategy
Key facts
- Where
- Houston and New York, United StatesSee the 2 sites
- Phase
- Phase 1/2
Where in United States
- MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- Tisch Cancer Institute at Mount SinaiNew York, United StatesNo longer taking part
Trial details
- Who runs it
- STCube, Inc.
- Trial code
- NCT06016270
- Record updated
- 5 September 2025
- Original description
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 full original descriptionShow less
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.
Inclusion: 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: 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; Receiving high doses of steroids or other immunosuppressive medications; Active or history of non-infectious pneumonitis requiring treatment with steroids; History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to screening; Known active leptomeningeal disease (carcinomatous meningitis); History of another primary malignancy with protocol-defined exceptions; Active or history of autoimmune disease requiring systemic treatment; Active hepatitis B or C infection; Active uncontrolled viral, fungal, or bacterial infection including tuberculosis; History of severe hypersensitivity reaction to a monoclonal antibody treatment; History of severe hypersensitivity reaction or ≥ Grade 3 adverse event (AE) to paclitaxel treatment; 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; QT Corrected for Fridericia's method (QTcF) > 470 ms at screening; Known active and uncontrolled central nervous system (CNS) metastases; Pregnant or breastfeeding female patients; Lack of resolution of any toxicity to max Grade 1 (except alopecia).