BGB-A317 in combination with BGB-290 in Advanced Solid Tumors
Research type
Research Study
Full title
A Phase 1/1b, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activity of the anti-PD-1 Monoclonal Antibody BGB-A317 in combination with the PARP inhibitor BGB-290 in Subjects with Advanced Solid Tumors.
IRAS ID
236586
Contact name
Mira-Bianca Stanescu
Contact email
Sponsor organisation
BeiGene Ltd
Eudract number
2017-003580-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 28 days
Research summary
Cancer refers to any one of a large number of diseases characterised by the development of abnormal (cancer) cells. The cell is the basic building block of the body. However, cancer cells can divide uncontrollably and have the ability to invade and destroy normal body tissue.
One type of cancer treatment is immunotherapy, where drugs called antibodies are administered to help the body’s immune system to detect and eliminate certain types of cancer cells. BGB-A317 is an antibody made by Beigene (the Sponsor of this study) that is a type of immunotherapy.
Another anticancer therapy blocks an enzyme called PARP (poly ADP ribose polymerase). Blocking the PARP enzyme may prevent cancer cells from being able to repair their DNA damage. The class of drugs that block the PARP enzyme is called PARP inhibitors. BGB-290 is a PARP inhibitor made by Beigene.
This is a two-part study to investigate the effects of BGB-A317 in combination with BGB-290 on patients with advanced solid tumours.
The United Kingdom will participate only in part B of the study.
Part A of the study will evaluate combinations of BGB-290 and BGB-A317 in increasing doses to determine dose safety. Part B is a dose expansion study where the recommended dose determined from Part A will be used for treatment. Part B will assess the ability of the study drugs to treat the solid tumours, the safety of the study drugs, the way that the study drugs work when given together, and the body’s immune response to the study drugs.BeiGene is the sponsor of this study which will take place worldwide. It is anticipated that approximately 180 participants will be enrolled in Part B of the study. For each participant, the study will last a maximum of 2.5 years plus survival follow-up visits.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/0611
Date of REC Opinion
13 Jul 2018
REC opinion
Further Information Favourable Opinion