Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
NCT04272034 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2025-10-16
Summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.
Conditions
- Advanced Solid Tumors
- MSI-H/dMMR Tumors
- Cutaneous Squamous Cell Carcinoma
- Urothelial Carcinoma, HCC
- Cervical Cancer
- Esophageal Squamous Cell Carcinoma
- Merkel Cell Carcinoma
- Small-cell Lung Cancer
- Mesothelioma
- PD-L1 Amplified Tumor (9p24.1)
- Nasopharyngeal Carcinoma
- Cyclin-dependent Kinase 12 Mutated Tumors
- Basal Cell Carcinoma (Unresectable or Metastatic)
- Sarcomatoid Renal Cell Carcinoma
- Clear Cell Ovarian or Endometrial Carcinoma
- Anal Carcinoma
- Squamous Cell Penile Carcinoma
- DNA Polymerase Epsilon Mutated Tumors (P286R and V411L)
Interventions
- DRUG
-
INCB099318
INCB099318 administered orally in 20 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Louis Viviers, MD · Incyte Corporation
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-26
- Primary Completion
- 2024-08-16
- Completion
- 2024-08-16
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Denmark
- Finland
- Norway
- Sweden
- United Kingdom
Study Locations
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