Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 140
Summary
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Advanced Solid Tumors
- Anal Carcinoma
- Nasopharyngeal Carcinoma
- Basal Cell Carcinoma (Unresectable or Metastatic)
- Urothelial Carcinoma, HCC
- Sarcomatoid Renal Cell Carcinoma
- Cervical Cancer
- Clear Cell Ovarian or Endometrial Carcinoma
- Cyclin-dependent Kinase 12 Mutated Tumors
- DNA Polymerase Epsilon Mutated Tumors (P286R and V411L)
- MSI-H/dMMR Tumors
- Esophageal Squamous Cell Carcinoma
- Merkel Cell Carcinoma
- PD-L1 Amplified Tumor (9p24.1)
- Squamous Cell Penile Carcinoma
- Mesothelioma
- Small Cell Lung Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04272034
- Collaborators
- Not Provided
- Investigators
- Study Director: Louis Viviers, MD Incyte Corporation