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

June 2, 2026 updated by: AbbVie

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus /ID# 217536
    • Central District
      • Petah Tikva, Central District, Israel, 4941492
        • Rabin Medical Center. /ID# 217537
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 217538
  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East /ID# 218537
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital /ID# 218536
  • South Korea
      • Seoul, South Korea, 03722
        • Yonsei University Health System Severance Hospital /ID# 222281
    • Gyeonggido
      • Seongnam, Gyeonggido, South Korea, 13496
        • CHA Bundang Medical Center /ID# 232514
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center /ID# 222280
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center /ID# 222906
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall de Hebron /ID# 215729
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 215110
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro /ID# 215102
  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital /ID# 222602
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital /ID# 222603
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham - Main /ID# 213605
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group, PA /ID# 215383
    • California
      • Stanford, California, United States, 94305-2200
        • Duplicate_Stanford University School of Med /ID# 213450
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Univ of Colorado Cancer Center /ID# 215295
    • Florida
      • Miami, Florida, United States, 33136-1002
        • Sylvester Comprehensive Cancer Center /ID# 216433
      • Tampa, Florida, United States, 33612-9416
        • Moffitt Cancer Center /ID# 215101
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University-School of Medicine /ID# 213453
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University /ID# 211088
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC /ID# 215326
    • Texas
      • Houston, Texas, United States, 77030-3306
        • Oncology Consultants /ID# 215932
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center /ID# 215876
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists - Fairfax /ID# 216427

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cofetuzumab Pelidotin
Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks
Drug: Cofetuzumab Pelidotin
Intravenous (IV) infusion
Other Names:
  • ABBV-647

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 3 years
ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR).
Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR)
Time Frame: Up to approximately 3 years
DOR is defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression or death from any cause.
Up to approximately 3 years
Progression Free Survival (PFS)
Time Frame: Up to approximately 3 years
PFS is defined as the time from the participant's first dose of study drug until radiographic progression or death from any cause.
Up to approximately 3 years
Overall Survival (OS)
Time Frame: Up to approximately 3 years
OS is defined as the time from the participant's first dose of study drug until death from any cause.
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

Pfizer

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2020

Primary Completion (Actual)

May 7, 2026

Study Completion (Actual)

May 7, 2026

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M19-611
  • 2019-003472-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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