Phase 1b Study of INCMGA00012 in Advanced Solid Tumors.
Research type
Research Study
Full title
A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors.
IRAS ID
249706
Contact name
Udai Banerji
Contact email
Sponsor organisation
Incyte Biosciences UK Ltd
Eudract number
2018-001130-17
Duration of Study in the UK
4 years, 4 months, 27 days
Research summary
This is an open-label, nonrandomized, multicenter, Phase 1b study.
This is an “open-label” study; this means that the patient and the study research staff will know what treatments the patient will be receiving. The study consists of two parts and participants will be enrolled in one of the two treatment groups ( Group A: INCMGA00012 with epacadostat or Group B: INCMGA00012 with INCB050465)Part 1 (dose escalation) will determine the safe and tolerable dose of INCMGA00012 in combination with different therapies; a small set of participants will be given a certain amount of INCMGA00012 with Epacadostat or INCB050465 and evaluated for side effects before a higher dose of INCMGA00012 with epacadostat or INCB050465 is given to the next group of patients. Approximately 24 participants will be included in the epacadostat dose escalation and up to approximately 18 participants will be enrolled in the dose escalation for INCB050465
Part 2 (dose expansion) will test the selected doses from Part 1 in more participants to explore further safety and any effect on the cancer. Approximately 25 participants will be enrolled at the selected dose.
The patient population for this study will be adult men and women of at least 18 years of age who have advanced solid tumours. Up to 100 participants will be enrolled in each part of the study. The study will be conducted at approximately 15 sites globally.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/1716
Date of REC Opinion
14 Dec 2018
REC opinion
Further Information Favourable Opinion