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

Sutro Biopharma

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Luveltamab tazevibulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06555263

REFRaME-L1

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Luveltamab tazevibulin

Experimental group

Description:

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.

Treatment:

Drug: Luveltamab tazevibulin