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

A Phase 2, Open-label Study Evaluating STRO-002, an Anti-folate Receptor Alpha (FOLR1) Antibody-Drug Conjugate, in Subjects With Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Expressing FOLR1

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

Study Overview

• Status: Withdrawn
• Conditions: Lung Cancer; Lung Cancer Metastatic; Lung Cancer, Non-small Cell; Lung Cancer, Nonsmall Cell; Lung Cancer Non-small Cell Stage IV; Lung Cancer Non-Small Cell Stage IIIB
• Intervention / Treatment: Drug: Luveltamab tazevibulin

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 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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • UC San Diego Health - Moores Cancer Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
  • Florida
    • Lake Mary, Florida, United States, 32746
      • Florida Cancer Specialists & Research Institute (FCS)
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital - Cancer Center of South Florida
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • HealthPartners Frauenshuh Cancer Center
    • Saint Paul, Minnesota, United States, 55101
      • HealthPartners Cancer Center at Regions Hospital
  • Texas
    • Dallas, Texas, United States, 75230
      • Mary Crowley Cancer Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Luveltamab tazevibulin; 4.3 mg/kg q3w Eligible subjects with stable disease (SD) may escalate to 5.2 mg/kg q3w after Cycle 4, with Sponsor approval.

Drug: Luveltamab tazevibulin; Luveltamab tazevibulin is an antibody-drug conjugate (ADC) targeting folate receptor α (FRα or FOLR1). It consists of an IgG1 antibody (SP8166) conjugated to cathepsin cleavable 3-aminophenyl hemiasterlin payload, yielding a homogenous ADC with a drug antibody ratio of four. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death.; Other Names: STRO-002; luvelta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Best response of complete response (CR) or partial response (PR) per RECIST 1.1	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR) per Investigator's assessment.	Confirmed CR or PR from the first documented response to the date of documented disease progression or death.	up to 24 months
Progression Free Survival (PFS) by RECIST v1.1 per Investigator's assessment.	Time between the date of first dose and the first date of documented progression or death	up to 24 months
Incidence and severity of adverse events and clinical laboratory abnormalities	Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities.	up to 24 months
ADC concentration	To evaluate the PK of luveltamab tazevibulin	up to 24 months
Total antibody concentration	To evaluate the PK of luveltamab tazevibulin	up to 24 months
Cytotoxic warhead concentration	To evaluate the PK of luveltamab tazevibulin	up to 24 months

Collaborators and Investigators

• Sponsor: Sutro Biopharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: ADC; folate receptor alpha; antibody drug conjugate; FRα; FOLR1; FolRα; Luveltamab tazevibulin; STRO-002; Luvelta
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: REFRaME-L1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No