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

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: Active, not recruiting
• Conditions: Cancer; Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Cofetuzumab Pelidotin

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 217536
  • Petakh Tikva, 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
• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center /ID# 222280
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center /ID# 222906
  • Gyeonggido
    • Seongnam si, Gyeonggido, Korea, Republic of, 13496
      • CHA University Bundang Medical Center /ID# 232514
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Yonsei University Health System Severance Hospital /ID# 222281
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'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
      • 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
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 213453
  • Ohio
    • Columbus, Ohio, United States, 43210-1257
      • 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

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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)	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)	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)	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

• Sponsor: AbbVie
• Collaborators: Pfizer
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Estimated): February 13, 2024
• Study Completion (Estimated): February 13, 2024

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 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Antibody Drug Conjugate; Non-small Cell Lung Cancer (NCSLC); PTK7-Expressing Tumor; cofetuzumab pelidotin; ABBV-647
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Immunologic Factors; Immunoconjugates; Cofetuzumab pelidotin
• 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