Terminated Early

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.

Inclusion Criteria:

• Histologically or cytologically confirmed non-squamous/adenocarcinoma or adenosquamous NSCLC that is either unresectable Stage IIIb/c disease not amenable for definitive chemoradiation, or Stage IV.
• Age ≥ 18 years
• ECOG performance status 0 to 1.
• Received at least 2 but no more than 4 prior lines of systemic therapy for advanced NSCLC
• Disease progression during or following the most recent systemic anti-cancer therapy.
• Positive FOLR1 expression per central testing
• At least 1 measurable target lesion per RECIST 1.1
• Adequate organ function

Exclusion Criteria:

• Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor
• Untreated central nervous system metastases
• Ongoing immunosuppressive therapy, except for treated brain metastases, per criterion above.
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment
• Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
• Previous solid organ transplantation
• Concurrent participation in another therapeutic treatment trial