Phase 1/2 study of INCB001158 in advanced or metastatic solid tumors
Research type
Research Study
Full title
A Phase 1/2 Study to Evaluate the Safety, Tolerability and Efficacy of INCB001158 in Combination With Chemotherapy, in Subjects With Advanced or Metastatic Solid Tumors
IRAS ID
235038
Contact name
Rebecca Kristeleit
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2017-002904-29
Duration of Study in the UK
1 years, 4 months, 6 days
Research summary
There is emerging evidence to suggest that some chemotherapies may influence an immune response leading to cell death, elimination of immunosuppresive cells or sensitization of tumor cells to immune effector cells. Given that various types of chemotherapy has shown to have different immune responses this trial is combining the Arginase inhibitor INCB01158 with a variety of chemotherapy regimens as a treatment option for patients with limited or suboptimal options. This is an open-label non randomized phase 1/2 study to evaluate the safety, tolerability and antitumor activity of INCB01158 in combination with 3 different chemotherapy regimens in subjects with advanced or metastatic solid tumors. Phase 2, tumor expansion, will evaluate overall response rate to determine whether the combinations have a sufficient antitumor activitiy to warrant further testing. Subjects with advanced or metastatic colorectal cancer (CRC) biliary tract cancer (BTC) gastroesophageal cancer (GC) endometrial cancer (EC) and ovarian cancer (OC). Up to 222 subjects (if starting dose level is 75mg in Phase 1) or up to a total of 249 (if starting dose level is 50mg in phase 1) are planned for enrollment. Phase 1 dose escalation - up to 87 (if starting dose level is 75mg in phase 1) or up to 114 (if starting dose level is 50mg in phase 1) evaluable subjects. Phase 2 tumor expansion approximately 55 to 135 evaluable subjects will be enrolled. Subjects participation will start after signing the ICF and is expected for 12-18 months per individual subject, as long as subjects are deriving benefits, tolerating the regimen and do not meet any of the withdrawal criteria.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/1900
Date of REC Opinion
20 Dec 2017
REC opinion
Further Information Favourable Opinion