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

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AbbVie

Status and phase

Active, not recruiting
Phase 1

Conditions

Non-small Cell Lung Cancer (NSCLC)
Cancer

Treatments

Drug: Cofetuzumab Pelidotin

Study type

Interventional

Funder types

Industry

Identifiers

NCT04189614
M19-611
2019-003472-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

65 participants in 1 patient group

Cofetuzumab Pelidotin
Experimental group
Description:
Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks
Treatment:
Drug: Cofetuzumab Pelidotin

Trial contacts and locations

26

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Data sourced from clinicaltrials.gov

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