M14-239 Open Label Teliso-V in c-Met Postive NSCLC Patients
Research type
Research Study
Full title
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
IRAS ID
253551
Contact name
Denis Talbot
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2018-001772-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 18 days
Research summary
This study is investigating whether Telisotuzumab Vedotin (ABBV-399 or Teliso-V) improves response rate and survival in patients who are c-Met+ with Non-Small Cell Lung Cancer. c-Met is a cell surface receptor that is overexpressed in over 50% of solid tumours including NSCLC. Teliso-V is an antibody drug conjugate that specifically targets cells that express c-Met; once it targets the cell it delivers a cytotoxin to the cancer cell resulting in cell death.
The study is split into two stages. During stage one, c-Met+ subjects will be recruited based on their NSCLC type and placed into 5 different groups. The response rate for each group will be assessed and those patients showing a good response will enter stage two of the study. During stage 2, groups with patients responding well to treatment will be able to continue recruiting subjects. Groups where patients are not showing a good response may stop recruiting in stage 1 but those subjects already enrolled can continue on treatment.
Prior to screening, subjects will be asked to provide either archival tumour tissue or a fresh biopsy (if archival tumour tissue is unavailable) of their tumour to establish if they are c-Met+. Patients with c-Met+ tumours will be able to enter screening which is 28 days long. Eligible patients will enter the treatment phase and receive Teliso-V every two weeks and have their tumour assessed every 6 weeks. Subjects will continue receiving treatment until their tumour progresses or when they or their doctor decides to discontinue them from the study. Subjects that discontinue due to a reason other than progression of disease will continue their 6 weekly tumour assessments until they progress. Subjects whose tumour has progressed will enter the survival follow up period where research sites will follow the patients up to check on their survival status.REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/0050
Date of REC Opinion
7 Feb 2019
REC opinion
Further Information Favourable Opinion