Clinical trial NCT04189614: An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Cancer
Non-small Cell Lung Cancer (NSCLC)
Keywords: Non-small Cell Lung Cancer (NCSLC)
PTK7-Expressing Tumor
Antibody Drug Conjugate
cofetuzumab pelidotin
ABBV-647
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2019-12-06
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to approximately 3 years
measure: Progression Free Survival (PFS)
timeFrame: Up to approximately 3 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Main /ID# 213605
state: Alabama
city: Springdale
country: United States
facility: Highlands Oncology Group, PA /ID# 215383
state: Arkansas
city: Stanford
country: United States
facility: Stanford University School of Med /ID# 213450
state: California
city: Aurora
country: United States
facility: Univ of Colorado Cancer Center /ID# 215295
state: Colorado
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center /ID# 216433
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center /ID# 215101
state: Florida
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 213453
state: Missouri
city: Columbus
country: United States
facility: The Ohio State University /ID# 211088
state: Ohio
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC /ID# 215326
state: Tennessee
city: Houston
country: United States
facility: Oncology Consultants /ID# 215932
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center /ID# 215876
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists - Fairfax /ID# 216427
state: Virginia
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 217536
state: H_efa
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 217538
state: Tel-Aviv
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 217537
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 218537
state: Chiba
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 218536
state: Tokyo
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center /ID# 232514
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 222281
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 222280
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 222906
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 215729
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 215110
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro /ID# 215102
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 222602
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 222603
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: