NCT06555263

Study to Investigate Luveltamab Tazevibulin in Adults With Advanced or Metastatic Non-small Cell Lung Cancer

A Phase 2, Open-label Study Evaluating STRO-002, an Anti-folate Receptor Alpha (FOLR1) Antibody-Drug Conjugate, in Subjects With Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Expressing FOLR1

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sutro Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2 study evaluating STRO-002 in subjects with previously treated advanced or metastatic non-small cell lung cancer expressing FOLR1

Detailed description

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.

Conditions

• Lung Cancer
• Lung Cancer Metastatic
• Lung Cancer, Nonsmall Cell
• Lung Cancer Non-Small Cell Stage IIIB
• Lung Cancer Non-small Cell Stage IV
• Lung Cancer, Non-small Cell

Interventions

Type	Name	Description
DRUG	Luveltamab tazevibulin	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.

Timeline

• Start date: 2024-08-21
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-08-15
• Last updated: 2025-08-22

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study