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

Phase 2

Recruiting

• Conditions: Lung Cancer; Lung Cancer Non-Small Cell Stage IIIB; Lung Cancer Metastatic; Lung Cancer, Non-small Cell; Lung Cancer, Nonsmall Cell; Lung Cancer Non-small Cell Stage IV
• Interventions: Drug: Luveltamab tazevibulin

• Registration Number: NCT06555263
• Lead Sponsor: Sutro Biopharma, Inc.

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.

Study Timeline

• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-12
• Study First Posted: 2024-08-15
• Study Start: 2024-08-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Luveltamab tazevibulin	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	up to 24 months	Best response of complete response (CR) or partial response (PR) per RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
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
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.
ADC 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
Total antibody concentration	up to 24 months	To evaluate the PK of luveltamab tazevibulin

Trial Locations

Locations (4)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

HealthPartners Cancer Research Center; 🇺🇸 St. Paul, Minnesota, United States

Florida Cancer Specialists; 🇺🇸 Lake Mary, Florida, United States

Mary Crowley Cancer Research; 🇺🇸 Dallas, Texas, United States