Trials / Terminated
TerminatedNCT04272034
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-03-26
- Primary completion
- 2024-08-16
- Completion
- 2024-08-16
- First posted
- 2020-02-17
- Last updated
- 2025-10-16
Locations
24 sites across 7 countries: United States, Belgium, Denmark, Finland, Norway, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04272034. Inclusion in this directory is not an endorsement.