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

NCT06555263 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: REFRaME-L1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Best response of complete response (CR) or partial response (PR) per RECIST 1.1

  up to 24 months

Secondary Outcomes (6)

• Duration of Response (DOR) per Investigator's assessment.

  up to 24 months

• Progression Free Survival (PFS) by RECIST v1.1 per Investigator's assessment.

  up to 24 months

• Incidence and severity of adverse events and clinical laboratory abnormalities

  up to 24 months

• ADC concentration

  up to 24 months

• Total antibody concentration

  up to 24 months

Study Arms (1)

Luveltamab tazevibulin

EXPERIMENTAL

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.

Drug: Luveltamab tazevibulin

Interventions

Luveltamab tazevibulin DRUG

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.

Also known as: STRO-002, luvelta

Luveltamab tazevibulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sutro Biopharma, Inc.: lead

Study Sites (7)

UC San Diego Health - Moores Cancer Center

La Jolla, California, 92037, United States

Location

Georgetown University Medical Center - Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20057, United States

Location

Florida Cancer Specialists & Research Institute (FCS)

Lake Mary, Florida, 32746, United States

Location

Tampa General Hospital - Cancer Center of South Florida

Tampa, Florida, 33606, United States

Location

HealthPartners Frauenshuh Cancer Center

Saint Louis Park, Minnesota, 55426, United States

Location

HealthPartners Cancer Center at Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: August 21, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2024-11

Locations

US (7)