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

NCT04189614

Last updated date
Study Location
Highlands Oncology Group /ID# 215383
Springdale, Arkansas, 72762, United States
Contact
847.283.8955

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cancer, Non-small Cell Lung Cancer (NSCLC)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Cancer, Non-small Cell Lung Cancer (NSCLC)An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer
NCT04189614
  1. Springdale, Arkansas
  2. Birmingham, Alabama
  3. Stanford, California
  4. Aurora, Colorado
  5. Miami, Florida
  6. Tampa, Florida
  7. Saint Louis, Missouri
  8. Columbus, Ohio
  9. Nashville, Tennessee
  10. Houston, Texas
  11. Houston, Texas
  12. Fairfax, Virginia
  13. Marseille, Bouches-du-Rhone
  14. Paris,
  15. Petakh Tikva, Tel-Aviv
  16. Haifa,
  17. Ramat Gan,
  18. Kashiwa-shi, Chiba
  19. Chuo-ku, Tokyo
  20. Seoul, Seoul Teugbyeolsi
  21. Seoul, Seoul Teugbyeolsi
  22. Seoul,
  23. Barcelona,
  24. Madrid,
  25. Madrid,
  26. Tainan City, Tainan
  27. Taoyuan City,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Cancer
  • Non-small Cell Lung Cancer (NSCLC)
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
 (submitted: December 5, 2019)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER847.283.8955[email protected]
Listed Location Countries  ICMJE France,   Israel,   Japan,   Korea, Republic of,   Spain,   Taiwan,   United States
Removed Location Countries  
 
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
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
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:AbbVie Inc.AbbVie
PRS Account AbbVie
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP