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

Primary Purpose

Cancer, Non-small Cell Lung Cancer (NSCLC)

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Cofetuzumab Pelidotin
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Non-small Cell Lung Cancer (NCSLC), PTK7-Expressing Tumor, Antibody Drug Conjugate, cofetuzumab pelidotin, ABBV-647, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham - Main /ID# 213605
  • Highlands Oncology Group, PA /ID# 215383
  • Stanford University School of Med /ID# 213450
  • Univ of Colorado Cancer Center /ID# 215295
  • Sylvester Comprehensive Cancer Center /ID# 216433
  • Moffitt Cancer Center /ID# 215101
  • Washington University-School of Medicine /ID# 213453
  • The Ohio State University /ID# 211088
  • Tennessee Oncology, PLLC /ID# 215326
  • Oncology Consultants /ID# 215932
  • University of Texas MD Anderson Cancer Center /ID# 215876
  • Virginia Cancer Specialists - Fairfax /ID# 216427
  • The Chaim Sheba Medical Center /ID# 217538
  • Rambam Health Care Campus /ID# 217536
  • Rabin Medical Center /ID# 217537
  • National Cancer Center Hospital East /ID# 218537
  • National Cancer Center Hospital /ID# 218536
  • CHA University Bundang Medical Center /ID# 232514
  • Yonsei University Health System Severance Hospital /ID# 222281
  • Asan Medical Center /ID# 222280
  • Samsung Medical Center /ID# 222906
  • Hospital Universitario Vall d'Hebron /ID# 215729
  • Hospital Universitario Fundacion Jimenez Diaz /ID# 215110
  • Hospital Universitario HM Sanchinarro /ID# 215102
  • National Cheng Kung University Hospital /ID# 222602
  • Linkou Chang Gung Memorial Hospital /ID# 222603

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cofetuzumab Pelidotin

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
Overall Survival (OS)
OS is defined as the time from the participant's first dose of study drug until death from any cause.

Full Information

First Posted
December 5, 2019
Last Updated
June 26, 2023
Sponsor
AbbVie
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04189614
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
February 13, 2024 (Anticipated)
Study Completion Date
February 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cofetuzumab Pelidotin
Arm Type
Experimental
Arm Description
Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Cofetuzumab Pelidotin
Other Intervention Name(s)
ABBV-647
Intervention Description
Intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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).
Time Frame
Up to approximately 3 years
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
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.
Time Frame
Up to approximately 3 years
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from the participant's first dose of study drug until radiographic progression or death from any cause.
Time Frame
Up to approximately 3 years
Title
Overall Survival (OS)
Description
OS is defined as the time from the participant's first dose of study drug until death from any cause.
Time Frame
Up to approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham - Main /ID# 213605
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Highlands Oncology Group, PA /ID# 215383
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Stanford University School of Med /ID# 213450
City
Stanford
State/Province
California
ZIP/Postal Code
94305-2200
Country
United States
Facility Name
Univ of Colorado Cancer Center /ID# 215295
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center /ID# 216433
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1002
Country
United States
Facility Name
Moffitt Cancer Center /ID# 215101
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9416
Country
United States
Facility Name
Washington University-School of Medicine /ID# 213453
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Ohio State University /ID# 211088
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1257
Country
United States
Facility Name
Tennessee Oncology, PLLC /ID# 215326
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Oncology Consultants /ID# 215932
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3306
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center /ID# 215876
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Cancer Specialists - Fairfax /ID# 216427
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
The Chaim Sheba Medical Center /ID# 217538
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 217536
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Rabin Medical Center /ID# 217537
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
National Cancer Center Hospital East /ID# 218537
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Cancer Center Hospital /ID# 218536
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
CHA University Bundang Medical Center /ID# 232514
City
Seongnam si
State/Province
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Yonsei University Health System Severance Hospital /ID# 222281
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 222280
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 222906
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Hospital Universitario Vall d'Hebron /ID# 215729
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz /ID# 215110
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro /ID# 215102
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
National Cheng Kung University Hospital /ID# 222602
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital /ID# 222603
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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