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

NCT04189614 | Terminated Phase 1 FDA Drug

• 2 other identifiers: M19-6112019-003472-39
• Study Type: interventional
• Target: 65
• Locations: 6 countries
• Sites: 26

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Survival (OS)

  Up to approximately 3 years

• Progression Free Survival (PFS)

  Up to approximately 3 years

• Duration of Response (DOR)

  Up to approximately 3 years

Study Arms (1)

Cofetuzumab Pelidotin

EXPERIMENTAL

Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks

Drug: Cofetuzumab Pelidotin

Interventions

Cofetuzumab Pelidotin DRUG

Intravenous (IV) infusion

Also known as: ABBV-647

Cofetuzumab Pelidotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead
• Pfizer: collaborator

Study Sites (26)

University of Alabama at Birmingham - Main /ID# 213605

Birmingham, Alabama, 35233, United States

Location

Highlands Oncology Group, PA /ID# 215383

Springdale, Arkansas, 72762, United States

Location

Duplicate_Stanford University School of Med /ID# 213450

Stanford, California, 94305-2200, United States

Location

Univ of Colorado Cancer Center /ID# 215295

Aurora, Colorado, 80045, United States

Location

Sylvester Comprehensive Cancer Center /ID# 216433

Miami, Florida, 33136-1002, United States

Location

Moffitt Cancer Center /ID# 215101

Tampa, Florida, 33612-9416, United States

Location

Washington University-School of Medicine /ID# 213453

St Louis, Missouri, 63110, United States

Location

The Ohio State University /ID# 211088

Columbus, Ohio, 43210, United States

Location

Tennessee Oncology, PLLC /ID# 215326

Nashville, Tennessee, 37203, United States

Location

Oncology Consultants /ID# 215932

Houston, Texas, 77030-3306, United States

Location

University of Texas MD Anderson Cancer Center /ID# 215876

Houston, Texas, 77030, United States

Location

Virginia Cancer Specialists - Fairfax /ID# 216427

Fairfax, Virginia, 22031, United States

Location

Rabin Medical Center. /ID# 217537

Petah Tikva, Central District, 4941492, Israel

Location

The Chaim Sheba Medical Center /ID# 217538

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Rambam Health Care Campus /ID# 217536

Haifa, 3109601, Israel

Location

National Cancer Center Hospital East /ID# 218537

Kashiwa-shi, Chiba, 277-8577, Japan

Location

National Cancer Center Hospital /ID# 218536

Chuo-ku, Tokyo, 104-0045, Japan

Location

CHA Bundang Medical Center /ID# 232514

Seongnam, Gyeonggido, 13496, South Korea

Location

Asan Medical Center /ID# 222280

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Samsung Medical Center /ID# 222906

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Yonsei University Health System Severance Hospital /ID# 222281

Seoul, 03722, South Korea

Location

Hospital Universitario Vall de Hebron /ID# 215729

Barcelona, 08035, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz /ID# 215110

Madrid, 28040, Spain

Location

Hospital Universitario HM Sanchinarro /ID# 215102

Madrid, 28050, Spain

Location

National Cheng Kung University Hospital /ID# 222602

Tainan, 704, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 222603

Taoyuan City, 333, Taiwan

Location

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

cofetuzumab pelidotin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 6, 2019
• Study Start: February 13, 2020
• Primary Completion: May 7, 2026
• Study Completion: May 7, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); IL (3); KR (4); TW (2); ES (3); JP (2)