WITHDRAWN

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

Conditions

Lung Cancer Lung Cancer Metastatic Lung Cancer, Nonsmall Cell Lung Cancer Non-Small Cell Stage IIIB Lung Cancer Non-small Cell Stage IV Lung Cancer, Non-small Cell FOLR1 folate receptor alpha FolRα FRα antibody drug conjugate ADC Luveltamab tazevibulin STRO-002 Luvelta

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-08-21

Study Completion:2025-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:WITHDRAWN

Study ID

NCT06555263

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

UC San Diego Health - Moores Cancer Center

La Jolla, California, 92037

United States

Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

Washington, District of Columbia, 20057

United States

Florida Cancer Specialists & Research Institute (FCS)

Lake Mary, Florida, 32746

United States

Tampa General Hospital - Cancer Center of South Florida

Tampa, Florida, 33606

United States

HealthPartners Frauenshuh Cancer Center

Saint Louis Park, Minnesota, 55426

United States

HealthPartners Cancer Center at Regions Hospital

Saint Paul, Minnesota, 55101

United States

Mary Crowley Cancer Research

Dallas, Texas, 75230

United States

Collaborators and Investigators

Sponsor: Sutro Biopharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-21

Study Completion Date2025-05-01

Study Record Updates

Study Start Date2024-08-21

Study Completion Date2025-05-01

Terms related to this study

Keywords Provided by Researchers

FOLR1
folate receptor alpha
FolRα
FRα
antibody drug conjugate
ADC
Luveltamab tazevibulin
STRO-002
Luvelta

Additional Relevant MeSH Terms

Lung Cancer
Lung Cancer Metastatic
Lung Cancer, Nonsmall Cell
Lung Cancer Non-Small Cell Stage IIIB
Lung Cancer Non-small Cell Stage IV
Lung Cancer, Non-small Cell