Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 1
Funding Agency/Sponsor
Industrial
Disease
Thoracic Oncology
Enrollment Eligibility
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