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

ACTIVE_NOT_RECRUITINGPHASE1

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

A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer

NCT04189614•AbbVie

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (26)

University of Alabama at Birmingham - Main /ID# 213605

Birmingham, Alabama, United States

Highlands Oncology Group, PA /ID# 215383

Springdale, Arkansas, United States

Duplicate_Stanford University School of Med /ID# 213450

Stanford, California, United States

Univ of Colorado Cancer Center /ID# 215295

Aurora, Colorado, United States

Sylvester Comprehensive Cancer Center /ID# 216433

Miami, Florida, United States

Moffitt Cancer Center /ID# 215101

Tampa, Florida, United States

Washington University-School of Medicine /ID# 213453

St Louis, Missouri, United States

The Ohio State University /ID# 211088

Columbus, Ohio, United States

Tennessee Oncology, PLLC /ID# 215326

Nashville, Tennessee, United States

Oncology Consultants /ID# 215932

Houston, Texas, United States

Key Dates

Start Date

February 13, 2020

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

July 16, 2025

Enrollment

ACTUAL participants

Conditions

CancerNon-small Cell Lung Cancer (NSCLC)

Interventions

Cofetuzumab Pelidotin

DRUG

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NCT05198830

Lung AdenocarcinomaLung Large Cell Carcinoma+2 more

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RECRUITINGPHASE2

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NCT04929028

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

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Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors