An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer

NCT ID: NCT04189614

Last Updated: 2025-07-16

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

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-13

Study Completion Date

2025-12-31

Brief Summary

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This study is being done to determine the efficacy and safety of cofetuzumab pelidotin in the PTK7-expressing, recurrent non-small cell lung cancer (NSCLC) population.

Detailed Description

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Conditions

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Cancer Non-small Cell Lung Cancer (NSCLC)

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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Cofetuzumab Pelidotin

Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks

Group Type EXPERIMENTAL

Cofetuzumab Pelidotin

Intervention Type DRUG

Intravenous (IV) infusion

Interventions

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Cofetuzumab Pelidotin

Intravenous (IV) infusion

Intervention Type DRUG

Other Intervention Names

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ABBV-647

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed non-small cell lung cancer (NSCLC) with PTK7-expressing tumor using an immunohistochemistry (IHC) assay previously validated at a designated laboratory
* Recurrent NSCLC that has progressed after treatment with at least the following approved therapies with demonstrated clinical benefit: a platinum-based chemotherapy doublet and an immune checkpoint inhibitor for tumors without targetable genetic alterations; a platinum-based chemotherapy doublet and targeted agent(s) for tumors with targeted genetic alterations
* Received ≤ 2 prior lines of systemic therapy, including no more than 1 line of systemic cytotoxic chemotherapy (≤ 3 prior lines for tumors treated with targeted agent(s) for genetic alterations, including no more than 1 line of systemic chemotherapy)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Adequate bone marrow, renal, and hepatic function per the protocol

Exclusion Criteria

* Known uncontrolled metastases to the central nervous system (CNS). Participants with CNS metastases may be eligible provided that definitive therapy has been given, and participants are asymptomatic and off systemic steroids and anticonvulsants used for management of brain metastases for at least 2 weeks prior to the first dose of study drug
* Unresolved clinically significant adverse events Grade ≥ 2 from prior anticancer therapy (with the exception of alopecia or anemia)
* Has clinically significant medical condition(s) as described in the protocol
* Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days prior to the first dose of study drug (no washout period required for participants on EGFR tyrosine kinase inhibitors). Palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is not subject to a washout period
* Received anti-cancer herbal therapies within 7 days prior to the first dose of study drug
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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University of Alabama at Birmingham - Main /ID# 213605

Birmingham, Alabama, United States

Site Status

Highlands Oncology Group, PA /ID# 215383

Springdale, Arkansas, United States

Site Status

Duplicate_Stanford University School of Med /ID# 213450

Stanford, California, United States

Site Status

Univ of Colorado Cancer Center /ID# 215295

Aurora, Colorado, United States

Site Status

Sylvester Comprehensive Cancer Center /ID# 216433

Miami, Florida, United States

Site Status

Moffitt Cancer Center /ID# 215101

Tampa, Florida, United States

Site Status

Washington University-School of Medicine /ID# 213453

St Louis, Missouri, United States

Site Status

The Ohio State University /ID# 211088

Columbus, Ohio, United States

Site Status

Tennessee Oncology, PLLC /ID# 215326

Nashville, Tennessee, United States

Site Status

Oncology Consultants /ID# 215932

Houston, Texas, United States

Site Status

University of Texas MD Anderson Cancer Center /ID# 215876

Houston, Texas, United States

Site Status

Virginia Cancer Specialists - Fairfax /ID# 216427

Fairfax, Virginia, United States

Site Status

The Chaim Sheba Medical Center /ID# 217538

Ramat Gan, Tel Aviv, Israel

Site Status

Rambam Health Care Campus /ID# 217536

Haifa, , Israel

Site Status

Rabin Medical Center /ID# 217537

Petah Tikva, , Israel

Site Status

National Cancer Center Hospital East /ID# 218537

Kashiwa-shi, Chiba, Japan

Site Status

National Cancer Center Hospital /ID# 218536

Chuo-ku, Tokyo, Japan

Site Status

CHA Bundang Medical Center /ID# 232514

Seongnam, Gyeonggido, South Korea

Site Status

Asan Medical Center /ID# 222280

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Samsung Medical Center /ID# 222906

Seoul, Seoul Teugbyeolsi, South Korea

Site Status

Yonsei University Health System Severance Hospital /ID# 222281

Seoul, , South Korea

Site Status

Hospital Universitario Vall d'Hebron /ID# 215729

Barcelona, , Spain

Site Status

Hospital Universitario Fundacion Jimenez Diaz /ID# 215110

Madrid, , Spain

Site Status

Hospital Universitario HM Sanchinarro /ID# 215102

Madrid, , Spain

Site Status

National Cheng Kung University Hospital /ID# 222602

Tainan City, , Taiwan

Site Status

Linkou Chang Gung Memorial Hospital /ID# 222603

Taoyuan, , Taiwan

Site Status

Countries

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United States Israel Japan South Korea Spain Taiwan

Other Identifiers

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2019-003472-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M19-611

Identifier Type: -

Identifier Source: org_study_id

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