Clinical trial NCT06555263: Study to Investigate Luveltamab Tazevibulin in Adults with Advanced or Metastatic Non-small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Keywords: FOLR1
folate receptor alpha
FolRα
FRα
antibody drug conjugate
ADC
Luveltamab tazevibulin
STRO-002
Luvelta
Lead sponsor: Sutro Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 24 months
Secondary outcomes:
measure: Duration of Response (DOR) per Investigator's assessment.
timeFrame: up to 24 months
measure: Progression Free Survival (PFS) by RECIST v1.1 per Investigator's assessment.
timeFrame: up to 24 months
measure: Incidence and severity of adverse events and clinical laboratory abnormalities
timeFrame: up to 24 months
measure: ADC concentration
timeFrame: up to 24 months
measure: Total antibody concentration
timeFrame: up to 24 months
measure: Cytotoxic warhead concentration
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Lake Mary
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: St. Paul
country: United States
facility: HealthPartners Cancer Research Center
state: Minnesota
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
Study officials:
References: