Telisotuzumab vedotin
DrugIntravenous (IV) Infusion
Other names: ABBV-399
NCT Number: NCT06568939
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 80 to 90 sites worldwide.
Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Suporte Nutricional e Quimioterapia LTDA - PRONUTRIR /ID# 273203, Fortaleza, Ceará, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous (IV) Infusion
Other names: ABBV-399
Time frame: Up to Approximately 3 Years
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Time frame: Up to Approximately 3 Years
ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication (any-grade and Grade >= 2).
Time frame: Up to Approximately 3 Years
Peripheral neuropathy is defined by peripheral neuropathy SMQ (narrow) (any-grade and Grade >= 2)
Time frame: Up to Approximately 3 Years
Treatment-emergent ocular surface disorders defined by corneal epitheliopathy company MedDRA query (CMQ) (any-grade and Grade >= 2).
Time frame: Up to Approximately 3 Years
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Time frame: Up to Approximately 3 Years
An AE is defined as any untoward medical occurrence, inappropriate participant management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational medical device.
Time frame: Up to Approximately 3 Years
OR will be defined as achieving confirmed complete response (CR) or confirmed partial response (PR) based on response evaluation criteria in solid tumors (RECIST), version 1.1.
Time frame: Up to 26 Weeks
Concentrations of telisotuzumab vedotin conjugate in serum.
Time frame: Up to 26 Weeks
Concentrations of MMAE payload in plasma.
Time frame: Up to 26 Weeks
Percentage of participants with ADAs of telisotuzumab vedotin.
Time frame: Up to 26 Weeks
Percentage of participants with nADAs of telisotuzumab vedotin.
Time frame: Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years
The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in patients participating in cancer clinical trials. PRO-CTCAE includes 124 items representing 78 symptomatic toxicities drawn from the Common Terminology Criteria for Adverse Events (CTCAE). PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. All questions employ a 7-day recall period and are scored from 0 to 4 (or 0/1 for absent/present).
Time frame: Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years
The GP5 item ("I am bothered by side effects of treatment") of FACT-G is used to assess overall treatment tolerability in patients by assessing the overall side effect impact on participants.
Time frame: Up to Approximately 3 Years
DoR is defined for confirmed responders as the time from the participants' initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause.
Time frame: Up to Approximately 3 Years
PFS will be defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause.
Time frame: Up to Approximately 3 Years
OS will be defined as the time from randomization to death from any cause.
Contact information is provided by the study sponsor or research team.
AbbVie
Industry
A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02146170
Bronchial Neoplasms, Carcinoma, Bronchogenic
Bethesda, Maryland, United States
View Trial DetailsNCT06218914
Bronchial Neoplasms, Carcinoma, Bronchogenic
Duarte, California, United States
View Trial DetailsNCT02682667
Blood Protein Disorders, Bronchial Neoplasms
Bethesda, Maryland, United States
View Trial DetailsNCT07554339
Bronchial Neoplasms, Carcinoma, Bronchogenic
Lincoln, Nebraska, United States
View Trial Details