Moffitt Cancer Center: Clinical Trial 20605

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Clinical Trial 20605

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04189614

Phase: Phase I
Prinicipal Investigator: Alberto Chiappori

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study 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

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.

Objective

The primary objective is to assess the objective response rate (ORR) of cofetuzumab pelidotin in subjects with PTK7-expressing, recurrent NSCLC. The secondary objectives are to assess: Duration of response (DoR). Progression-free survival (PFS). Overall survival (OS). Safety and tolerability.

Treatments

Therapies

Medications

Cofetuzumab Pelidotin ()

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 > 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

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.