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

Last updated: August 18, 2025
Sponsor: Sutro Biopharma, Inc.
Overall Status: Trial Not Available

Phase

2

Condition

Non-small Cell Lung Cancer

Lung Cancer

Cancer

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

Treatment Group(s): 1
Primary Treatment: Luveltamab tazevibulin
Phase: 2
Study Start date:
August 21, 2024
Estimated Completion Date:
May 01, 2025

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

  • UC San Diego Health - Moores Cancer Center

    La Jolla, California 92037
    United States

    Site Not Available

  • UC San Diego Health - Moores Cancer Center

    La Jolla 5363943, California 5332921 92037
    United States

    Site Not Available

  • Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

    Washington, District of Columbia 20057
    United States

    Site Not Available

  • Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

    Washington D.C. 4140963, District of Columbia 4138106 20057
    United States

    Site Not Available

  • Florida Cancer Specialists

    Lake Mary, Florida 32746
    United States

    Active - Recruiting

  • Florida Cancer Specialists & Research Institute (FCS)

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Tampa General Hospital - Cancer Center of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Florida Cancer Specialists & Research Institute (FCS)

    Lake Mary 4161373, Florida 4155751 32746
    United States

    Site Not Available

  • Tampa General Hospital - Cancer Center of South Florida

    Tampa 4174757, Florida 4155751 33606
    United States

    Site Not Available

  • HealthPartners Frauenshuh Cancer Center

    Saint Louis Park, Minnesota 55426
    United States

    Site Not Available

  • HealthPartners Cancer Center at Regions Hospital

    Saint Paul, Minnesota 55101
    United States

    Site Not Available

  • HealthPartners Cancer Research Center

    St. Paul, Minnesota 55101
    United States

    Site Not Available

  • HealthPartners Frauenshuh Cancer Center

    Saint Louis Park 5045021, Minnesota 5037779 55426
    United States

    Site Not Available

  • HealthPartners Cancer Center at Regions Hospital

    Saint Paul 5045360, Minnesota 5037779 55101
    United States

    Site Not Available

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • Mary Crowley Cancer Research

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

Map preview placeholder

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.