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Search / Trial NCT06555263

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

Launched by SUTRO BIOPHARMA, INC. · Aug 12, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Folr1 Folate Receptor Alpha Fol Rα Frα Antibody Drug Conjugate Adc Luveltamab Tazevibulin Stro 002 Luvelta

ClinConnect Summary

This clinical trial is studying a new treatment called Luveltamab Tazevibulin for adults with advanced or metastatic non-small cell lung cancer (NSCLC). This type of lung cancer can be difficult to treat, especially if it has spread to other parts of the body. The trial is focusing on patients whose cancer has progressed despite previous treatments and who have specific markers in their cancer cells that make them suitable for this study.

To be eligible for this trial, participants must be at least 18 years old, have a confirmed diagnosis of a certain type of NSCLC, and have received between two and four prior treatments for their cancer. They also need to have measurable cancer that can be tracked during the study. If you join the trial, you will receive the new treatment and be monitored closely for its effects. This trial is currently recruiting participants, and it aims to provide valuable information about how effective this new option may be for people dealing with advanced lung cancer.

Gender

ALL

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

About Sutro Biopharma, Inc.

Sutro Biopharma, Inc. is a clinical-stage biopharmaceutical company dedicated to advancing novel therapeutics for the treatment of cancer and autoimmune diseases. Utilizing its proprietary integrated drug discovery platform, Sutro focuses on the development of next-generation antibody-drug conjugates (ADCs) and other innovative protein-based therapeutics. The company's commitment to precision medicine is reflected in its portfolio of differentiated candidates, which aim to improve patient outcomes through targeted therapies. With a robust pipeline and collaborations with leading pharmaceutical firms, Sutro Biopharma is poised to make significant contributions to the field of oncology and beyond.

Locations

Tampa, Florida, United States

Dallas, Texas, United States

Lake Mary, Florida, United States

St. Paul, Minnesota, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported