Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors

HepatoCellular Carcinoma Clinical Trial

Official title:

A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04242199
• Other study ID #: INCB 99280-112
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 4, 2020
• Est. completion date: October 31, 2025

Study information

• Verified date: May 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 182
• Est. completion date: October 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.

• Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.

• Eastern Cooperative Oncology Group performance status score of 0 or 1.

• Life expectancy > 12 weeks.

• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• Laboratory values outside the Protocol-defined ranges.

• Clinically significant cardiac disease.

• History or presence of an electrocardiogram that, in the investigator's opinion, is clinically meaningful.

• Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).

• Known additional malignancy that is progressing or requires active treatment.

• Has not recovered to = Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment.

• Prior receipt of an anti-PD-L1 therapy.

• Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.

• A 28-day washout for systemic antibiotics is required.

• Probiotic usage while on study and during screening is prohibited.

• Active infection requiring systemic therapy.

• Known history of Human Immunodeficiency Virus (HIV)

• Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Carcinoma
• Carcinoma, Merkel Cell
• Carcinoma, Squamous Cell
• Cervical Cancer
• Cutaneous Squamous Cell Carcinoma
• Esophageal Squamous Cell Carcinoma
• HepatoCellular Carcinoma
• Merkel Cell Carcinoma
• Mesothelioma
• MSI-H/dMMR Tumors
• Nasopharyngeal Carcinoma
• Neoplasms
• PD-L1 Amplified Tumor (9p24.1)
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer
• Urothelial Carcinoma

Intervention

Drug:
• INCB099280
INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle

Locations

Country	Name	City	State
Australia	Chris Obrien Lifehouse	Camperdown	New South Wales
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Nucleus Network Pty Ltd	Melbourne	Victoria
Australia	Linear Clinical Research	Nedlands	Western Australia
Belgium	Cliniques Universitaires Ucl Saint-Luc	Brussels
Belgium	Institut Jules Bordet Clinical Trials Conduct Unit	Brussels
Belgium	Universitair Ziekenhuis Antwerpen (Uza)	Edegem
Belgium	Ghent University Hospital	Ghent
Belgium	Universitaire Ziekenhuis Leuven - Gasthuisberg	Leuven
France	Institut de Cancerologie de L Ouest - Site Paul Papin	Angers
France	Institut Bergonie	Bordeaux
France	Chu Hopital de La Timone	Marseille Cedex 5
France	Centre Eugene Marquis	Rennes
France	Institut Gustave Roussy	Villejuif
Japan	National Cancer Center Hospital East	Chiba
Japan	National Cancer Center Hospital	Tokyo
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Henry Ford Hospital	Detroit	Michigan
United States	Md Anderson Cancer Center	Houston	Texas
United States	Upmc Cancercenter	Pittsburgh	Pennsylvania
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment-emergent adverse events	Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 30 days after last dose of study drug.	Up to approximately 25 months
Secondary	Cmax of INCB099280	Maximum observed plasma concentration	Up to approximately 3 months
Secondary	tmax of INCB099280	Time to maximum plasma concentration	Up to approximately 3 months
Secondary	Cmin of INCB099280	Minimum observed plasma concentration over the dose interval	Up to approximately 3 months
Secondary	AUC0-t of INCB099280	Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t	Up to approximately 3 months
Secondary	t½ of INCB099280	Apparent terminal-phase disposition half-life	Up to approximately 3 months
Secondary	?z of INCB099280	Terminal elimination rate constant	Up to approximately 3 months
Secondary	CL/F of INCB099280	Oral dose clearance	Up to approximately 3 months
Secondary	Vz/F of INCB099280	Apparent oral dose volume of distribution	Up to approximately 3 months