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
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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ACTIVE_NOT_RECRUITING
PHASE1
65 participants
INTERVENTIONAL
2020-02-13
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cofetuzumab Pelidotin
Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks
Cofetuzumab Pelidotin
Intravenous (IV) infusion
Interventions
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Cofetuzumab Pelidotin
Intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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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
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
University of Texas MD Anderson Cancer Center /ID# 215876
Houston, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 216427
Fairfax, Virginia, United States
The Chaim Sheba Medical Center /ID# 217538
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus /ID# 217536
Haifa, , Israel
Rabin Medical Center /ID# 217537
Petah Tikva, , Israel
National Cancer Center Hospital East /ID# 218537
Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital /ID# 218536
Chuo-ku, Tokyo, Japan
CHA Bundang Medical Center /ID# 232514
Seongnam, Gyeonggido, South Korea
Asan Medical Center /ID# 222280
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 222906
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 222281
Seoul, , South Korea
Hospital Universitario Vall d'Hebron /ID# 215729
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 215110
Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 215102
Madrid, , Spain
National Cheng Kung University Hospital /ID# 222602
Tainan City, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 222603
Taoyuan, , Taiwan
Countries
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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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