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

Last updated: November 5, 2024
Sponsor: Sutro Biopharma, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Cancer

Lung Disease

Treatment

Luveltamab tazevibulin

Clinical Study ID

NCT06555263
REFRaME-L1
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed non-squamous/adenocarcinoma oradenosquamous NSCLC that is either unresectable Stage IIIb/c disease not amenablefor 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 advancedNSCLC

  • Disease progression during or following the most recent systemic anti-cancertherapy.

  • Positive FOLR1 expression per central testing

  • At least 1 measurable target lesion per RECIST 1.1

  • Adequate organ function

Exclusion

Exclusion Criteria:

  • Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulininhibitor

  • Untreated central nervous system metastases

  • Ongoing immunosuppressive therapy, except for treated brain metastases, percriterion above.

  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapyor to antibody-related fusion protein treatment

  • Pre-existing clinically significant ocular disorders, severe chronic obstructivepulmonary disease or asthma, clinically significant cardiac or cerebrovasculardisease, or other significant concurrent, uncontrolled medical condition

  • Previous solid organ transplantation

  • Concurrent participation in another therapeutic treatment trial

Study Design

Total Participants: 43
Treatment Group(s): 1
Primary Treatment: Luveltamab tazevibulin
Phase: 2
Study Start date:
August 21, 2024
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Florida Cancer Specialists

    Lake Mary, Florida 32746
    United States

    Active - Recruiting

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • HealthPartners Cancer Research Center

    St. Paul, Minnesota 55101
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.