INCYTE 54828-101 Advanced Malignancies - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out the dose of the study drug INCB054828 that is safe and tolerable in people with advanced cancer.

What is the Condition Being Studied?

Advanced cancers

Who Can Participate in the Study?

Part 1: Adults with any advanced solid tumor malignancy.
Part 2: Adults with documented FGF/FGFR alteration.
Part 3: Adults (+/- FGF/FGFR alterations) and solid tumor malignancies for which gemcitabine + cisplatin, docetaxel, trastuzumab, and PD-1 treatment is relevant.

- Must provide archival tumor tissue or have a fresh tumor biopsy.

Age Group

What is Involved?

This study will be divided into three parts.

Part 1 is looking for the maximum tolerated dose of the study drug.
Part 2 will look at the dose selected from Part 1 in squamous non-small lung cancer, gastric cancer, urothelial cancer, endometrial cancer, multiple myeloma (MM), and myeloproliferative neoplasms (MPN).
Part 3 will look at the study drug in combination with gemcitabine and cisplatin, docetaxel, pembrolizumab, trastuzumab or INCMGA00012.

All patients will be required to:
- Give multiple blood and urine samples during the study
- Come to the study center for a series of physical exams, tests and scans (Computerized tomography (CT) or Magnetic resonance imaging (MRI))
- Have an eye exam

Study Details

Full Title
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00061567
NCT: NCT02393248
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center