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

Ki vehet részt

• 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

Ki nem vehet részt

• 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)