Clinical Trials /

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

NCT04189614

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: M19-611
  • SECONDARY ID: 2019-003472-39
  • NCT ID: NCT04189614

Conditions

  • Cancer
  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DrugSynonymsArms
Cofetuzumab PelidotinABBV-647Cofetuzumab Pelidotin

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cofetuzumab PelidotinExperimentalParticipants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks
  • Cofetuzumab Pelidotin

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to approximately 3 years
Safety Issue:
Description: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

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Non-small Cell Lung Cancer (NCSLC)
  • PTK7-Expressing Tumor
  • Antibody Drug Conjugate
  • Cofetuzumab Pelidotin
  • ABBV-647
  • Cancer

Last Updated

December 5, 2019