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

Sponsor: Sutro Biopharma, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06555263

Patient View

This Phase 2, open-label study evaluates the efficacy and safety of luveltamab tazevibulin, an intravenous anti-FOLR1 ADC, in adults with advanced NSCLC expressing FOLR1. Eligible participants must have progressed after 2-4 prior therapies and meet specific health criteria. Exclusions include prior FOLR1 ADC treatment and significant medical conditions.

Patient Parameters

Program Overview

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

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.

Eligibility Criteria

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

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