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

Stopped early · Phase 1

Conditions studied: Cancer, Non-small Cell Lung Cancer (NSCLC)

In brief

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.

Key facts

Study ID

NCT04189614

Run by

AbbVie

People needed

65

Starts

2020-02-13

Expected to finish

2026-05-07

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Rabin Medical Center. /ID# 217537 — Petah Tikva, Central District, Israel
• The Chaim Sheba Medical Center /ID# 217538 — Ramat Gan, Tel Aviv, Israel
• Rambam Health Care Campus /ID# 217536 — Haifa, 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 de 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, Taiwan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.