An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer
NCT04189614
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- 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
- 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
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| 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 |
| ||||||
| 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 | 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:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
| ||||||
| 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 |
| ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | AbbVie | ||||||
| Study Sponsor ICMJE | AbbVie | ||||||
| Collaborators ICMJE | Pfizer | ||||||
| Investigators ICMJE |
| ||||||
| 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 | |||||||