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

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04189614
Collaborator
Pfizer (Industry)
60
26
1
45
2.3
0.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cofetuzumab Pelidotin
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 13, 2020
Anticipated Primary Completion Date :
Nov 15, 2023
Anticipated Study Completion Date :
Nov 15, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) [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).

    Secondary Outcome Measures

    1. Duration of Response (DOR) [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.

    2. Progression Free Survival (PFS) [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.

    3. Overall Survival (OS) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham - Main /ID# 213605 Birmingham Alabama United States 35233
    2 Highlands Oncology Group Springdale /ID# 215383 Springdale Arkansas United States 72762
    3 Stanford University School of Med /ID# 213450 Stanford California United States 94305-2200
    4 Univ of Colorado Cancer Center /ID# 215295 Aurora Colorado United States 80045
    5 Sylvester Comprehensive Cancer Center /ID# 216433 Miami Florida United States 33136-1002
    6 Moffitt Cancer Center /ID# 215101 Tampa Florida United States 33612-9416
    7 Washington University-School of Medicine /ID# 213453 Saint Louis Missouri United States 63110
    8 The Ohio State University /ID# 211088 Columbus Ohio United States 43210-1257
    9 Tennessee Oncology, PLLC /ID# 215326 Nashville Tennessee United States 37203
    10 Oncology Consultants /ID# 215932 Houston Texas United States 77030-3306
    11 University of Texas MD Anderson Cancer Center /ID# 215876 Houston Texas United States 77030
    12 Virginia Cancer Specialists - Fairfax /ID# 216427 Fairfax Virginia United States 22031
    13 The Chaim Sheba Medical Center /ID# 217538 Ramat Gan Tel-Aviv Israel 5265601
    14 Rambam Health Care Campus /ID# 217536 Haifa Israel 3109601
    15 Rabin Medical Center /ID# 217537 Petakh Tikva Israel 4941492
    16 National Cancer Center Hospital East /ID# 218537 Kashiwa-shi Chiba Japan 277-8577
    17 National Cancer Center Hospital /ID# 218536 Chuo-ku Tokyo Japan 104-0045
    18 CHA University Bundang Medical Center /ID# 232514 Seongnam si Gyeonggido Korea, Republic of 13496
    19 Yonsei University Health System Severance Hospital /ID# 222281 Seoul Seoul Teugbyeolsi Korea, Republic of 03722
    20 Asan Medical Center /ID# 222280 Seoul Korea, Republic of 05505
    21 Samsung Medical Center /ID# 222906 Seoul Korea, Republic of 06351
    22 Hospital Universitario Vall d'Hebron /ID# 215729 Barcelona Spain 08035
    23 Hospital Universitario Fundacion Jimenez Diaz /ID# 215110 Madrid Spain 28040
    24 Hospital Universitario HM Sanchinarro /ID# 215102 Madrid Spain 28050
    25 National Cheng Kung University Hospital /ID# 222602 Tainan Taiwan 704
    26 Linkou Chang Gung Memorial Hospital /ID# 222603 Taoyuan City Taiwan 333

    Sponsors and Collaborators

    • AbbVie
    • Pfizer

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT04189614
    Other Study ID Numbers:
    • M19-611
    • 2019-003472-39
    First Posted:
    Dec 6, 2019
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2022