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Clinical Trials List

Protocol NumberM19-611
NCT Number(ClinicalTrials.gov Identfier)NCT04189614
Active

2020-07-23 - 2024-02-15

Phase I

Recruiting2

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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.

  • Trial Applicant

    AbbVie

  • Sponsor

    AbbVie

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chih-Hsi Kuo Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wu-Chou Su Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

PTK7-Expressing, Recurrent Non-small Cell Lung Cancer (NSCLC)

Objectives

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.

Test Drug

Cofetuzumab Pelidotin (ABBV-647)

Active Ingredient

Cofetuzumab Pelidotin

Dosage Form

N/A

Dosage

N/A

Endpoints

Primary Outcome Measures:
1.Objective Response Rate (ORR)

Secondary Outcome Measures:
1.Overall Survival (OS)
2.Progression Free Survival (PFS)
3.Duration of Response (DOR)

Inclution Criteria

1.Histologically confirmed non-small cell lung cancer (NSCLC) with PTK7-expressing tumor using an immunohistochemistry (IHC) assay previously validated at a designated laboratory
2.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
3.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)
4.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
5.Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
6.Adequate bone marrow, renal, and hepatic function per the protocol

Exclusion Criteria

1.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
2.Unresolved clinically significant adverse events Grade ≥ 2 from prior anticancer therapy (with the exception of alopecia or anemia)
3.Has clinically significant medical condition(s) as described in the protocol
4.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
5.Received anti-cancer herbal therapies within 7 days prior to the first dose of study drug

The Estimated Number of Participants

  • Taiwan

    10 participants

  • Global

    40 participants

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