A Phase 2 study evaluating STRO-002 in subjects with previously treated advanced or metastatic non-small cell lung cancer expressing FOLR1
This is a multicenter, open-label study. The study is designed to assess the preliminary efficacy and safety of luveltamab tazevibulin, an anti-FOLR1 antibody drug conjugate (ADC) in previously treated subjects with advanced or metastatic NSCLC that expresses FOLR1. Subjects will receive luveltamab tazevibulin administered intravenously every 3 weeks until disease progression, intolerable toxicity, elective withdrawal from the study, or study termination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Luveltamab tazevibulin is an antibody-drug conjugate (ADC) targeting folate receptor α (FRα or FOLR1). It consists of an IgG1 antibody (SP8166) conjugated to cathepsin cleavable 3-aminophenyl hemiasterlin payload, yielding a homogenous ADC with a drug antibody ratio of four. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death.
UC San Diego Health - Moores Cancer Center
La Jolla, California, United States
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Florida Cancer Specialists & Research Institute (FCS)
Lake Mary, Florida, United States
Objective Response Rate (ORR)
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Time frame: up to 24 months
Duration of Response (DOR) per Investigator's assessment.
Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
Time frame: up to 24 months
Progression Free Survival (PFS) by RECIST v1.1 per Investigator's assessment.
Time between the date of first dose and the first date of documented progression or death
Time frame: up to 24 months
Incidence and severity of adverse events and clinical laboratory abnormalities
Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities.
Time frame: up to 24 months
ADC concentration
To evaluate the PK of luveltamab tazevibulin
Time frame: up to 24 months
Total antibody concentration
To evaluate the PK of luveltamab tazevibulin
Time frame: up to 24 months
Cytotoxic warhead concentration
To evaluate the PK of luveltamab tazevibulin
Time frame: up to 24 months
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Tampa General Hospital - Cancer Center of South Florida
Tampa, Florida, United States
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States
Mary Crowley Cancer Research
Dallas, Texas, United States