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.
The study will be conducted in 2 parts. Phase Ib will evaluate the safety of the combination of hSTC810 with a standard dose of paclitaxel using a 3+3 dose escalation design. Phase II will evaluate the efficacy of hSTC810 + paclitaxel combination therapy using a Simon 2-stage method.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
hSTC810 400 mg and paclitaxel 175 mg/m2 will be administered as an intravenous (IV) infusion Paclitaxel: 175 mg/m2 will be administered as an IV infusion
hSTC810 800 mg and paclitaxel 175 mg/m2 will be administered as an IV infusion
Tisch Cancer Institute at Mount Sinai
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Overall Response Rate (ORR)
Percentage of patients with confirmed Confirmed Response (CR) or Partial Response (PR) as defined by RECIST 1.1 at 3 months
Time frame: 3 months
Progression Free Survival (PFS) rate
Proportion of patients without documented progression of disease and alive at 6 months
Time frame: 6 months
Safety and tolerability
Incidence, causality, and nature of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 4 years
Overall Response Rate (ORR)
Investigator assessed ORR defined by RECIST 1.1
Time frame: Up to 4 years
Duration of Response (DoR)
Time from the date of first documented CR or PR until the date of documented progression or death
Time frame: Up to 4 years
Progression Free Survival (PFS)
Time from first dose until the date of objective disease progression or death
Time frame: Up to 4 years
Clinical Benefit Rate (CBR)
Percentage of evaluable patients with CR, PR, or Stable Disease (SD) lasting ≥ 24 weeks
Time frame: Up to 4 years
Overall Survival (OS)
Time from first dose of study drug until the date of death
Time frame: Up to 4 years
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Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, South Korea
Overall Survival (OS) rate
Proportion of patients alive at 12 months after the first dose of study drug
Time frame: 12 months
Maximum plasma concentration (Cmax)
Maximum plasma concentration of hSTC810 to evaluate PK parameters
Time frame: Up to 21 days
Area under the concentration-time curve from 0 to 21 days (AUC0-21)
AUC from 0 to 21 days to evaluate PK parameters
Time frame: Up to 21 days
Area under the concentration-time curve extrapolated from 0 to infinity (AUCo-inf)
AUC from time 0 to infinity to evaluate total drug exposure over time
Time frame: Up to 21 days
Incidence of anti-drug antibodies (ADA)
Number and percentage of patients with positive ADAs
Time frame: Up to 4 years