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

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ClinicalTrials.gov Identifier: NCT04189614
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : December 14, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE December 5, 2019
First Posted Date  ICMJE December 6, 2019
Last Update Posted Date December 14, 2020
Actual Study Start Date  ICMJE February 13, 2020
Estimated Primary Completion Date October 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2020)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2019)
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Non-small Cell Lung Cancer (NSCLC)
Intervention  ICMJE Drug: Cofetuzumab Pelidotin
Intravenous (IV) infusion
Other Name: ABBV-647
Study Arms  ICMJE Experimental: Cofetuzumab Pelidotin
Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks
Intervention: Drug: Cofetuzumab Pelidotin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 10, 2022
Estimated Primary Completion Date October 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Israel,   Japan,   Korea, Republic of,   Spain,   Taiwan,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT04189614
Other Study ID Numbers  ICMJE M19-611
2019-003472-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP