A Study to Evaluate Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer

Overview

About this study

The purpse of this study is to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for Telisotuzumab Vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate effectiveness in the selected population(s) (Stage 2).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult male or female, at least 18 years old.
  • Subjects must have c-Met+ NSCLC as assessed by an AbbVie designated IHC laboratory. Subject must submit archival or fresh tumor material for assessment of c-Met levels during the pre-screening period. If archival tissue is c-Met negative, 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 biopsy is not appropriate for a given subject, the subject may still be enrolled following investigator consultation with, and confirmation from, AbbVie.
  • Subjects have adequate bone marrow, renal, and hepatic function as follows:
    • Bone marrow:
    • Absolute neutrophil count (ANC) ≥ 1,000/mm^3;
    • Platelets ≥ 100,000/mm^3; Hemoglobin ≥ 9.0 g/dL.
    • Renal function: erum creatinine ≤ 1.5 × the Institution's Upper Limit of Normal (ULN) range or creatinine clearance ≥ 50 mL/min measured by 24-hour urine or estimated by the Cockcroft-Gault formula:
    • CrCl (mL/min) = (140 – age in years) × (weight in kg) (× 0.85 if female) 72 × serum creatinine (mg/dL).
    • Hepatic function:
    • Bilirubin ≤ 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN, and albumin ≥ 3.0 g/dL.
    • Hepatic function for subjects with liver metastases:
    • Bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 5.0 × ULN, and albumin ≥ 3.0 g/dL.
  • Subjects are willing and able to comply with procedures required in this protocol.
  • Subjects with histologically documented non-squamous NSCLC with known EGFR status (wild type or mutant; with site documented status). Of note, subjects with other actionable mutations are eligible as long as EGFR status is known and all other eligibility criteria are met.
  • Subjects must have locally advanced or metastatic NSCLC.
  • Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Subjects must have measurable disease per RECIST version 1.1 11. Subjects must not have adenosquamous histology.
  • Subjects must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting.
    • Multiple lines of TKIs targeting the same TK count as 1 line of therapy for the purposes of this eligibility criterion.
  • Subjects must 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).
  • Subjects should not have received prior c-Met-targeted antibody-based therapies.
  • 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.
    • Subjects must not have a history of other malignancies except:
    • Malignancy treated with curative intent and with no known active disease present for ≥ 2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • Adequately treated carcinoma in situ without current evidence of disease.
  • Subjects 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.
  • Subjects must not have unresolved clinically significant adverse events Grade ≥ 2 from prior anticancer therapy, except for alopecia or anemia.
  • Subjects must not have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
  • Subjects must not have received radiation therapy to the lung < 6 months prior to the first dose of telisotuzumab vedotin.
  • Subjects must not have a clinically significant condition(s) including, but not limited to, the following:
    • Grade ≥ 2 edema or lymphedema
  • Subjects must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of systemic cytotoxic chemotherapy) in the locally advanced or metastatic setting.
    • Multiple lines of TKIs targeting the same TK count as 1 line of therapy for the purposes of this eligibility criterion.
  • Subjects must 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).
  • Subjects should not have received prior c-Met-targeted antibody-based therapies.
  • 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.
  • Subjects must not have a history of other malignancies except:
    • Malignancy treated with curative intent and with no known active disease present for ≥ 2 years before the first dose of study drug and felt to be at low risk for recurrence by investigator.
    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • Adequately treated carcinoma in situ without current evidence of disease.
  • Subjects 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.
  • Subjects must not have unresolved clinically significant adverse events Grade ≥ 2 from prior anticancer therapy, except for alopecia or anemia.
  • Subjects must not have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
  • Subjects must not have received radiation therapy to the lung <6 months prior to the first dose of telisotuzumab vedotin.
  • Subjects must not have a clinically significant condition(s) including, but not limited to, the following:
    • Grade ≥ 2 edema or lymphedema
  • For all females of child-bearing potential, a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at baseline prior to the first dose of study drug.
  • Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from Study Day 1 through at least 6 months after the last dose of study drug.
  • Females who are not pregnant or breastfeeding, and are not considering becoming pregnant or donating eggs during the study or for approximately 6 months after the last dose of study drug.
  • Males who are sexually active with female partner(s) of childbearing potential, must agree, from Study Day 1 through 6 months after the last dose of study drug, to practice the protocolspecified contraception.
  • Males who are not considering fathering a child or donating sperm during the study or for approximately 6 months after the last dose of study drug.

Exclusion Criteria:

  • Has adenosquamous histology.
  • Subjects with metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery or radiotherapy).
  • 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 vedotin.
  • Has received live vaccine within 30 days of the first dose of telisotuzumab vedotin.
  • Subjects do not have a history of interstitial lung disease or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease or pneumonitis.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aaron Mansfield, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

-

Jacksonville, Fla.

Mayo Clinic principal investigator

Rami Manochakian, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Panayiotis Savvides, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20503284

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