Advanced Solid Tumors, Anal Carcinoma, Basal Cell Carcinoma (Unresectable or Metastatic), Cervical Cancer, Clear Cell Ovarian or Endometrial Carcinoma, Cutaneous Squamous Cell Carcinoma, Cyclin-dependent Kinase 12 Mutated Tumors, DNA Polymerase Epsilon Mutated Tumors (P286R and V411L), Esophageal Squamous Cell Carcinoma, Merkel Cell Carcinoma, Mesothelioma, MSI-H/dMMR Tumors, Nasopharyngeal Carcinoma, PD-L1 Amplified Tumor (9p24.1), Sarcomatoid Renal Cell Carcinoma, Small-cell Lung Cancer, Squamous Cell Penile Carcinoma, Urothelial Carcinoma, HCC
Conditions
Keywords
Advanced solid tumors
Brief summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
Interventions
DRUGINCB099318
INCB099318 administered orally in 20 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study consists of 2 parts. Part 1 is a dose-escalation design to identify the maximum tolerated dose and/or pharmacologically active dose for INCB099318. Part 2 is an expansion at 1 or more dose levels to further explore safety, preliminary efficacy, pharmacoketics, and pharmacodynamic effects.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment. * Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures. * ECOG performance status score of 0 or 1. * Life expectancy \> 12 weeks. * Willingness to avoid pregnancy or fathering children.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment-emergent adverse events | Up to approximately 25 months | Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 30 days after last dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t of INCB099318 | Up to approximately 3 months | Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t |
| tmax of INCB099318 | Up to approximately 3 months | Time to maximum plasma concentration |
| Cmax of INCB099318 | Up to approximately 3 months | Maximum observed plasma concentration |
| Cmin of INCB099318 | Up to approximately 3 months | Minimum observed plasma concentration over the dose interval |
| λz of INCB099318 | Up to approximately 3 months | Terminal elimination rate constant |
| CL/F of INCB099318 | Up to approximately 3 months | Oral dose clearance |
| Vz/F of INCB099318 | Up to approximately 3 months | Apparent oral dose volume of distribution |
| t½ of INCB099318 | Up to approximately 3 months | Apparent terminal-phase disposition half-life |
Countries
Belgium, Denmark, Finland, Norway, Sweden, United Kingdom, United States
Outcome results
None listed