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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04189614
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : August 5, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
AbbVie

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
Cancer Non-small Cell Lung Cancer (NSCLC) Drug: Cofetuzumab Pelidotin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 : February 12, 2020
Estimated Primary Completion Date : August 15, 2022
Estimated Study Completion Date : August 15, 2022

Resource links provided by the National Library of Medicine


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 Name: ABBV-647




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04189614


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
Show Show 27 study locations
Sponsors and Collaborators
AbbVie
Pfizer
Investigators
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Study Director: AbbVie Inc. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04189614    
Other Study ID Numbers: M19-611
2019-003472-39 ( EudraCT Number )
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Non-small Cell Lung Cancer (NCSLC)
PTK7-Expressing Tumor
Antibody Drug Conjugate
cofetuzumab pelidotin
ABBV-647
Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms