A Phase 1/2 Safety and Tolerability Study of INCAGN01949
Research type
Research Study
Full title
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
IRAS ID
213278
Contact name
Rebecca Kristeleit
Contact email
Sponsor organisation
Incyte Biosciences International Sarl
Eudract number
2016-002079-93
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 129,838
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
INCAGN01949 is an investigational drug that is being studied for use in the treatment of cancer. INCAGN01949 is an antibody designed to help the immune system (the part of the body that fights infections). The immune system includes T-cells, a type of white blood cell, that have the ability to fight cancer but are often stopped by the cancer cells, which allow the cancer to grow faster than the T-cells can fight back. INCAGN01949 is an antibody, or large protein, that recognises another protein and binds or sticks to it. INCAGN01949 only recognises and binds to a protein on the surface of some immune cells. When INCAGN01949 sticks to this protein, it has the potential to enhance the function of T-cells making them more able to find and fight the cancer.
This Study has 2 parts; the purpose of Part 1 is to determine what dose of INCAGN01949 is safe and well tolerated. This part of the Study will also investigate the ways in which this drug is broken down in the body and eliminated, as well as the effects that the drug may have on cancer. During Part 1 of the Study, certain dose levels of INCAGN01949 will be evaluated in small groups of participants for a certain period of time before giving a higher dose to the next group of participants. Participants will be observed for a minimum of 28 days before the dose is increased for the next group of participants. Enrolment in this part of the Study will continue until the highest dose that is safe and tolerated by most participants is found.
The purpose of Part 2 is to determine if the dose and treatment cycle of INCAGN01949 chosen from Part 1 is effective for treating specific types of cancer while gathering additional safety data.REC name
London - Central Research Ethics Committee
REC reference
17/LO/0247
Date of REC Opinion
20 Mar 2017
REC opinion
Further Information Favourable Opinion