Status:
WITHDRAWN
Study to Investigate Luveltamab Tazevibulin in Adults With Advanced or Metastatic Non-small Cell Lung Cancer
Lead Sponsor:
Sutro Biopharma, Inc.
Conditions:
Lung Cancer
Lung Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 treate...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06555263
Start Date
August 21 2024
End Date
May 1 2025
Last Update
August 22 2025
Active Locations (7)
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1
UC San Diego Health - Moores Cancer Center
La Jolla, California, United States, 92037
2
Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20057
3
Florida Cancer Specialists & Research Institute (FCS)
Lake Mary, Florida, United States, 32746
4
Tampa General Hospital - Cancer Center of South Florida
Tampa, Florida, United States, 33606