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

Cancer Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04189614
• Other study ID #: M19-611
• Secondary ID: 2019-003472-39
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 13, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• Cofetuzumab Pelidotin
Intravenous (IV) infusion

Locations

Country	Name	City	State
Israel	Rabin Medical Center /ID# 217537	Haifa
Israel	Rambam Health Care Campus /ID# 217536	Haifa	H_efa
Israel	The Chaim Sheba Medical Center /ID# 217538	Ramat Gan	Tel-Aviv
Japan	National Cancer Center Hospital /ID# 218536	Chuo-ku	Tokyo
Japan	National Cancer Center Hospital East /ID# 218537	Kashiwa-shi	Chiba
Korea, Republic of	CHA Bundang Medical Center /ID# 232514	Seongnam	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 222280	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 222906	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 222281	Seoul	Seoul Teugbyeolsi
Spain	Hospital Universitario Vall d'Hebron /ID# 215729	Barcelona
Spain	Hospital Universitario Fundacion Jimenez Diaz /ID# 215110	Madrid
Spain	Hospital Universitario HM Sanchinarro /ID# 215102	Madrid
Taiwan	National Cheng Kung University Hospital /ID# 222602	Tainan
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 222603	Taoyuan City
United States	Univ of Colorado Cancer Center /ID# 215295	Aurora	Colorado
United States	University of Alabama at Birmingham - Main /ID# 213605	Birmingham	Alabama
United States	The Ohio State University /ID# 211088	Columbus	Ohio
United States	Virginia Cancer Specialists - Fairfax /ID# 216427	Fairfax	Virginia
United States	Oncology Consultants /ID# 215932	Houston	Texas
United States	University of Texas MD Anderson Cancer Center /ID# 215876	Houston	Texas
United States	Sylvester Comprehensive Cancer Center /ID# 216433	Miami	Florida
United States	Tennessee Oncology, PLLC /ID# 215326	Nashville	Tennessee
United States	Washington University-School of Medicine /ID# 213453	Saint Louis	Missouri
United States	Highlands Oncology Group, PA /ID# 215383	Springdale	Arkansas
United States	Stanford University School of Med /ID# 213450	Stanford	California
United States	Moffitt Cancer Center /ID# 215101	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie	Pfizer

Countries where clinical trial is conducted

United States,  Israel,  Japan,  Korea, Republic of,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	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).	Up to approximately 3 years
Secondary	Duration of Response (DOR)	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.	Up to approximately 3 years
Secondary	Progression Free Survival (PFS)	PFS is defined as the time from the participant's first dose of study drug until radiographic progression or death from any cause.	Up to approximately 3 years
Secondary	Overall Survival (OS)	OS is defined as the time from the participant's first dose of study drug until death from any cause.	Up to approximately 3 years