Solid Tumors
Conditions
Sponsors
Incyte Biosciences Japan G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. First generation Japanese; subject was born in Japan and has not lived outside of Japan for a total of > 10 years and subject can trace maternal and paternal Japanese ancestry. 2.Part 1: Any histologically confirmed advanced solid tumor malignancy. Subjects enrolled at a lower dose level expansion cohort are required to have documented FGF/FGFR alterations and baseline and on-treatment tumor biopsy for testing of biomarkers. 3. Part 2: Any histologically confirmed advanced solid tumor malignancy with a FGF/FGFR alteration 4. Advanced or metastatic and recurrent cancer where an appropriate treatment option is not available. 5. Life expectancy > 12 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance status: Part 1: 0 or 1; Part 2: 0, 1, or 2. 7. Genomic testing is mandatory for all enrolled subjects. Archival tumor specimen of at least 7 slides or willingness to undergo a pretreatment tumor biopsy to provide a tumor block or at least 7 unstained slides. Archival tumor biopsies are acceptable at baseline and should be no more than 2 years old (preferably less than 1 year old and collected since the completion of the last treatment); subjects with samples older than 2 years old and/or with sequencing report from the central laboratory require approval from the sponsor medical monitor for exemption from tumor biopsy or tumor sample requirement.
Exclusion criteria
Exclusion criteria: 1. Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives (whichever is longer) before first dose of study drug (6 weeks for mitomycin-C or nitrosoureas, 7 days for tyrosine kinase inhibitors). 2. Prior receipt of a selective FGFR inhibitor. 3. Laboratory and medical history parameters outside Protocol-defined range. 4. History and/or current evidence of ectopic mineralization/calcification including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification. 5. Current evidence of corneal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, confirmed by ophthalmologic examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics pharmacodynamics 1. Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Defined as proportion of subjects who meet the response criteria (complete response + partial response) as appropriate for the tumor type. 2. Pharmacodynamics of INCB054828 assessed by changes in serum phosphorus level. Analyzed to look for differences that may be associated with response or safety as well as significant changes associated with treatment. 3. Observed Plasma Concentration of INCB054828. PK parameters will be calculated from the blood plasma concentrations of INCB054828 using standard noncompartmental (model independent) PK methods. | — |
Countries
Japan
Outcome results
None listed