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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Active, not recruiting
Sponsor
AbbVie

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.