CA008-002 Phase I/II study of mesothelin directed ADC in solid tumours
Research type
Research Study
Full title
A Phase I/IIa Study of BMS 986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects with Select Advanced Solid Tumours
IRAS ID
198196
Contact name
Jeff Evans
Contact email
Sponsor organisation
Bristol Myers Squibb
Eudract number
2014-002485-70
Clinicaltrials.gov Identifier
124,215, IND Number
Duration of Study in the UK
3 years, 1 months, 9 days
Research summary
CA008-002 is an early phase study for patients with one of five cancers – lung cancer, ovarian cancer, stomach cancer, pancreatic cancer and mesothelioma (a type of cancer usually occurring in the lungs). It will be available to these patients only after the chemotherapy or chemotherapy combination(s) generally accepted to be the standard of care for their respective tumours are no longer working.
BMS-986148 is an intravenous drug administered either once on a 21 day cycle, or broken up to 3 separate doses on a 28 day cycle. The drug will be given on an ongoing basis during the study whilst patients are still benefitting. It will be stopped sooner if the disease worsens, patient has a confirmed complete response or patients have any difficulty with side effects from the drug.
The primary purpose of study CA008-002 is to assess the safety and manageability of the drug BMS-986148. Other objectives of the study will look at how well the cancer responds to the drug, and to try to better understand its mechanism of action in relation to the immune system. Additional measurements (most often through blood tests) will be taken to look at other effects of the drug on the body, and to identify any biomarkers, which may help to identify patients who may respond best to this treatment.
Patients will be followed regularly throughout the trial, with blood tests, CT scans, monitoring of the eyes (by ophthalmologists) and the heart (by echocardiograms – an ultrasound test on the heart) to help ensure ongoing safety within the trial. Because it is an early phase study, it is too early to know if patients will benefit from taking part in the study. These results may add to the understanding of the condition, and may also be helpful for future patients.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0417
Date of REC Opinion
18 Jul 2016
REC opinion
Further Information Favourable Opinion