# Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

> **NCT04272034** · PHASE1 · TERMINATED · sponsor: **Incyte Corporation** · enrollment: 105 (actual)

## Conditions studied

- 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

## Key facts

- **NCT ID:** NCT04272034
- **Lead sponsor:** Incyte Corporation
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2021-03-26
- **Primary completion:** 2024-08-16
- **Final completion:** 2024-08-16
- **Target enrollment:** 105 (ACTUAL)
- **Why stopped:** A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
- **Last updated:** 2025-10-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04272034

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04272034, "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors". Retrieved via AI Analytics 2026-07-01 from https://api.ai-analytics.org/clinical/NCT04272034. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*