Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NL-OMON52936
NL-OMON52936RecruitingPhase 2

Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer - M14-239

AbbVie Deutschland GmbH & Co. KG0 sites5 target enrollmentStarted: TBDLast updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
5
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •Histologically confirmed non-small cell lung cancer (NSCLC) with known
  • •epidermal growth factor receptor (EGFR) status (wild type; with site documented
  • •status). Subjects in Monotherapy Cohort 1.6 mg/kg Q2W must have non-squamous
  • •EGFR wild type NSCLC.
  • •Has locally advanced or metastatic NSCLC.
  • •Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry
  • •(IHC) laboratory. Subject must submit archival or fresh tumor material for
  • •assessment of c-Met levels during the prescreening period. Tumor material from
  • •the primary tumor site and/or metastatic sites are allowed. If archival tissue
  • •is negative for c-Met overexpression, fresh biopsy material may be submitted
  • •for reassessment of c-Met expression.
  • •If a subject meets eligibility criteria for c-Met protein expression level
  • •based on archival tumor material, fresh tumor material for assessment of c-Met
  • •expression levels should be submitted prior to dosing of
  • •telisotuzumab vedotin. If it is determined that a pre-dose fresh biopsy is not
  • •appropriate for a given subject, the subject may still be enrolled at the
  • •investigator's discretion. AbbVie must be informed of this decision before
  • •Subjects who have progressed on systemic cytotoxic chemotherapy (or are
  • •ineligible for systemic cytotoxic chemotherapy) and an immune checkpoint
  • •inhibitor (as monotherapy or in combination with systemic cytotoxic
  • •chemotherapy, or ineligible for an immune checkpoint inhibitor), and prior
  • •anti-cancer therapies targeting driver gene alterations (if applicable).
  • •Subject must have received no more than 2 lines of prior systemic therapy
  • •(including no more than 1 line of prior systemic cytotoxic chemotherapy) in the
  • •locally advanced or metastatic setting.
  • •Subjects should not have received prior cMET-targeted antibody therapies.
  • •Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
  • •No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
  • •infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection,
  • •the subject must have a negative molecular (e.g., polymerase chain reaction
  • •[PCR]) test result or 2 negative antigen test results at least 24 hours apart.
  • •Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be
  • •screen failed and may only rescreen after they meet the following SARS-CoV-2
  • •infection viral clearance criteria:
  • •- At least 10 days since first positive PCR test result have passed in
  • •asymptomatic patients or 10 days since recovery, defined as resolution of fever
  • •without use of antipyretics and improvement
  • •in symptoms.

Exclusion Criteria

  • •Has adenosquamous histology.
  • •Has received anti-cancer therapy including chemotherapy, radiation therapy,
  • •immunotherapy, biologic, or any investigational therapy as described in the
  • •Subjects with metastases to the central nervous system (CNS) are eligible
  • •only after definitive therapy (such as surgery or radiotherapy) is provided and:
  • •* - There is no evidence of progression of CNS metastases at least 4 weeks
  • •after definitive therapy.
  • •* - They are asymptomatic and off or on a stable or reducing dose of systemic
  • •steroids and/or anticonvulsants for at least 2 weeks prior to first dose of
  • •telisotuzumab vedotin.
  • •Has a clinically significant condition(s) described in the protocol.
  • •Has unresolved clinically significant adverse events grade 2 from prior
  • •anticancer therapy, except for alopecia or anemia.
  • •Had major surgery within 21 days prior to the first dose of telisotuzumab
  • •Subject must not have a history of interstitial lung disease or pneumonitis
  • •that required treatment with systemic steroids.
  • •Subjects must not have any evidence of pulmonary fibrosis on screening
  • •imaging assessment or any history of pneumonitis or interstitial lung disease
  • •within 3 months of the planned first dose of the study drug. For imaging
  • •findings deemed clinically insignificant by the treating physician, subject may
  • •be eligible after discussion with and approval from the AbbVie medical monitor.
  • •Subjects must not have received radiation therapy to the lung <6 months prior
  • •to the first dose of telisotuzumab vedotin.
  • •Subjects must not have received any live vaccine within 30 days of the first
  • •dose of investigational product.

Investigators

Similar Trials

Recruiting
Phase 2
Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer
JPRN-jRCT2080224062AbbVie GK35
Active, not recruiting
Phase 1
Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Canceron-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2018-001772-38-GRAbbVie Deutschland GmbH & Co. KG270
Active, not recruiting
Phase 1
Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small CellLung Canceron-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2018-001772-38-ITABBVIE DEUTSCHLAND GMBH & CO. KG310
Active, not recruiting
Phase 1
Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Canceron-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864
CTIS2023-507902-15-00AbbVie Deutschland GmbH & Co. KG262
Active, not recruiting
Phase 1
Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Canceron-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2018-001772-38-BGAbbVie Deutschland GmbH & Co. KG270