Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Non-small Cell, Lung Cancer, Nonsmall Cell, Lung Cancer Non-Small Cell Stage IIIB, Lung Cancer Non-small Cell Stage IV
Conditions
Keywords
FOLR1, folate receptor alpha, FolRα, FRα, antibody drug conjugate, ADC, Luveltamab tazevibulin, STRO-002, Luvelta
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.
Interventions
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.
Sponsors
Sutro Biopharma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | up to 24 months | Best response of complete response (CR) or partial response (PR) per RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) per Investigator's assessment. | up to 24 months | Confirmed CR or PR from the first documented response to the date of documented disease progression or death. |
| Progression Free Survival (PFS) by RECIST v1.1 per Investigator's assessment. | up to 24 months | Time between the date of first dose and the first date of documented progression or death |
| ADC concentration | up to 24 months | To evaluate the PK of luveltamab tazevibulin |
| Total antibody concentration | up to 24 months | To evaluate the PK of luveltamab tazevibulin |
| Cytotoxic warhead concentration | up to 24 months | To evaluate the PK of luveltamab tazevibulin |
| Incidence and severity of adverse events and clinical laboratory abnormalities | up to 24 months | Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities. |
Countries
United States
Outcome results
None listed