Combination therapy of hSTC810 and paclitaxel for advanced small cell lung cancer
A Phase Ib/II Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer
This study is testing a new combination of two drugs, hSTC810 and paclitaxel, to see if it can help people with advanced small cell lung cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | STCube, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 8 sites (New York, New York and 7 other locations) |
| Trial ID | NCT06016270 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the safety and efficacy of hSTC810 in combination with paclitaxel for patients with relapsed or refractory extensive stage small cell lung cancer (ES-SCLC). The study is divided into two phases: Phase Ib focuses on determining the safety of the drug combination using a dose escalation design, while Phase II assesses the efficacy of the treatment using a Simon 2-stage method. Participants will receive either 400 mg or 800 mg of hSTC810 alongside a standard dose of paclitaxel.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed relapsed or refractory extensive stage small cell lung cancer after platinum-based chemotherapy.
Not a fit: Patients with active leptomeningeal disease or uncontrolled central nervous system metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced small cell lung cancer who have limited treatment choices.
How similar studies have performed: While this approach is novel in combining hSTC810 with paclitaxel, similar studies have shown promise in treating small cell lung cancer with combination therapies.
Eligibility criteria
Show full inclusion / exclusion 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: * 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
Where this trial is running
New York, New York and 7 other locations
- Tisch Cancer Institute at Mount Sinai — New York, New York, United States (Not_yet_recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Not_yet_recruiting)
- Korea University Anam Hospital — Seoul, Korea, Republic of (Recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- Seoul National University Bundang Hospital — Seoul, Korea, Republic of (Recruiting)
- The Catholic University of Korea St. Vincent's Hospital — Suwon, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Jiwon Hur, MD
- Email: hurjw@stcube.com
- Phone: 82-2-551-3370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.