Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT04189614

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 25 Locations for this study

See Locations Near You

University of Alabama at Birmingham - Main /ID# 213605
Birmingham Alabama, 35233, United States More Info
Site Coordinator
Contact
844-663-3742
Highlands Oncology Group, PA /ID# 215383
Springdale Arkansas, 72762, United States
Stanford University School of Med /ID# 213450
Stanford California, 94305, United States
Univ of Colorado Cancer Center /ID# 215295
Aurora Colorado, 80045, United States More Info
Site Coordinator
Contact
844-663-3742
Sylvester Comprehensive Cancer Center /ID# 216433
Miami Florida, 33136, United States More Info
Site Coordinator
Contact
844-663-3742
Moffitt Cancer Center /ID# 215101
Tampa Florida, 33612, United States More Info
Site Coordinator
Contact
844-663-3742
Washington University-School of Medicine /ID# 213453
Saint Louis Missouri, 63110, United States
The Ohio State University /ID# 211088
Columbus Ohio, 43210, United States
Tennessee Oncology, PLLC /ID# 215326
Nashville Tennessee, 37203, United States More Info
Site Coordinator
Contact
844-663-3742
Oncology Consultants /ID# 215932
Houston Texas, 77030, United States More Info
Site Coordinator
Contact
844-663-3742
University of Texas MD Anderson Cancer Center /ID# 215876
Houston Texas, 77030, United States More Info
Site Coordinator
Contact
844-663-3742
Virginia Cancer Specialists - Fairfax /ID# 216427
Fairfax Virginia, 22031, United States More Info
Site Coordinator
Contact
844-663-3742
The Chaim Sheba Medical Center /ID# 217538
Ramat Gan Tel-Aviv, 52656, Israel
Rambam Health Care Campus /ID# 217536
Haifa , 31096, Israel
Rabin Medical Center /ID# 217537
Petakh Tikva , 49414, Israel
National Cancer Center Hospital East /ID# 218537
Kashiwa-shi Chiba, 277-8, Japan
National Cancer Center Hospital /ID# 218536
Chuo-ku Tokyo, 104-0, Japan
CHA University Bundang Medical Center /ID# 232514
Seongnam si Gyeonggido, 13496, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 222281
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Asan Medical Center /ID# 222280
Seoul , 05505, Korea, Republic of
Samsung Medical Center /ID# 222906
Seoul , 06351, Korea, Republic of
Hospital Universitario Vall d'Hebron /ID# 215729
Barcelona , 08035, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 215110
Madrid , 28040, Spain
Hospital Universitario HM Sanchinarro /ID# 215102
Madrid , 28050, Spain
National Cheng Kung University Hospital /ID# 222602
Tainan , 704, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 222603
Taoyuan City , 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT04189614

Recruitment Status:

Recruiting

Sponsor:


AbbVie

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