A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer
Study Phase: Phase 1/Phase 2
Recruitment Status: Recruiting
Start Date: January 01, 2024
End Date: October 01, 2027
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
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Conditions:
- Lung Neoplasms
- Small Cell Lung Carcinoma