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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-21

Study Completion Date

2025-05-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Luveltamab tazevibulin

Intervention Type 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.

Interventions

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Luveltamab tazevibulin

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.

Intervention Type DRUG

Other Intervention Names

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STRO-002 luvelta

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No