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Mitogens

Subjects with HCC, cholangiocarcinoma, or esophageal, nasopharyngeal, or serous ovarian cancers, regardless of FGF/FGFR alteration status.

Subjects with HCC with FGF19 amplification.

Subjects with HCC without FGF19 amplification.

Subjects with cholangiocarcinoma or esophageal, nasopharyngeal, or serous ovarian cancers (regardless of FGF/FGFR status), or other solid tumor malignancies with documented FGF19/FGFR4 alteration.

In Part 1, initial cohort dose of INCB062079 at the protocol-defined starting dose, with subsequent dose escalations based on protocol-specific criteria. The recommended dose(s) from Part 1 will be taken forward into Part 2 cohorts.

INCB062079

Luis F. Vinas, MD

The purpose of this study is to evaluate the safety and tolerability, and determine the maximum tolerated dose of INCB062079 in subjects with advanced hepatocellular carcinoma and other malignancies.

An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies

A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies

An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.

Subjects with hepatocellular carcinoma (HCC) will be evaluated via modified RECIST for HCC; subjects with other advanced malignancies will be evaluated using standard RECIST v1.1.

Defined as maximum observed plasma concentration.

Defined as time to maximum plasma concentration.

Defined as minimum observed plasma concentration during the dosing interval.

Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration.

Defined as the apparent plasma terminal phase disposition half-life.

A plasma sample will be collected during screening for possible analysis of FGFR4 pathway mutations using tumor circulating DNA.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies	NCT03144661	Hepatocellular ... Cholangiocarcin... Esophageal Canc... Nasopharyngeal ... Ovarian Cancer Solid Tumors	INCB062079	18 Years -	Incyte Corporation
An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies	NCT03144661	Hepatocellular ... Cholangiocarcin... Esophageal Canc... Nasopharyngeal ... Ovarian Cancer Solid Tumors	INCB062079	18 Years -	Incyte Corporation

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