GARNET
Research type
Research Study
Full title
A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors
IRAS ID
219540
Contact name
Rebecca Kristeleit
Contact email
Sponsor organisation
TESARO, Inc
Eudract number
2016-000320-26
Clinicaltrials.gov Identifier
126472, IND
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This study is a Phase 1 dose escalation and cohort expansion study of TSR-042, an anti-PD-1 monoclonal antibody, in patients with advanced solid tumours.
The purpose of this study is to test a new investigational medicine, called TSR-042. The study medicine is designed to stop cancer from growing by helping the immune system to recognise and fight the cancer. The study medicine is designed to help the immune system by attaching to a protein called PD-1. This then stops one of the signals that keeps the immune system from recognising the cancer. This may help the immune system to attack and destroy cancer cells.
This study is divided into 3 parts. The purpose of this research study is to:
*Part 1: Evaluate the safety of the Study Medicine.
*Part 2A: Evaluate the safety of the Study Medicine using different doses and schedules (dose escalation).
*Part 2B: Evaluate the ability of the Study Medicine to reduce the size of the cancer (cohort expansion).UK participants would only participate in Part 2B. They are invited to participate in this research study because they have specific types of cancer which may include endometrial cancer (cancer of the uterus/womb), squamous cell carcinoma (a type of skin cancer), ovarian cancer, breast cancer, or non-small cell lung cancer.
Approximately 450 patients may participate in this study. Of those, approximately 390 patients may participate in Part 2B. Part 2B will take place in multiple countries worldwide.
It is not known how long participation in this study will last. The study medicine may be given for up to 2 years or 1) until the disease worsens, 2) the participant has unacceptable side effects, 3) the participant decides to stop taking part 4) The study doctor decides it is in the participant’s best interest to stop taking part or 5) if the sponsor stops the study.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0058
Date of REC Opinion
12 Apr 2017
REC opinion
Further Information Favourable Opinion