eligibility_summary
Eligible: Adults (≥18) with FOLR1+ non-squamous (adenocarcinoma/adenosquamous) NSCLC: unresectable stage IIIb/c not for definitive chemoradiation or stage IV, ECOG 0–1, 2–4 prior systemic lines with progression, measurable disease, adequate organ function. Exclude: prior FOLR1 or tubulin ADCs, untreated CNS mets, immunosuppression, severe mAb allergy, significant ocular/pulmonary/cardiac/cerebrovascular disease, organ transplant, other therapy trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06555263 (withdrawn early): Phase 2, open-label, single-arm study in previously treated advanced/metastatic FOLR1-positive NSCLC. Intervention: Luveltamab tazevibulin (STRO-002, Luvelta), an antibody-drug conjugate (ADC, IgG1 SP8166) targeting folate receptor-α (FOLR1). The ADC has a cathepsin-cleavable linker and a 3-aminophenyl hemiasterlin payload (SC209) with DAR≈4. Mechanism: FRα binding and internalization → lysosomal cleavage → release of SC209, a microtubule/tubulin polymerization inhibitor, inducing mitotic arrest and tumor cell death. Dosing: 4.3 mg/kg IV q3w, possible escalation to 5.2 mg/kg after cycle 4 with SD. Targets: FOLR1-expressing tumor cells, FRα endocytosis/lysosome pathway, tubulin/microtubule dynamics and mitotic machinery.