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

Phase 1

Completed

• Conditions: Cutaneous Squamous Cell Carcinoma; HepatoCellular Carcinoma; Mesothelioma; Advanced Solid Tumor; MSI-H/dMMR Tumors; Urothelial Carcinoma; Esophageal Squamous Cell Carcinoma; Small-cell Lung Cancer; Cervical Cancer; Merkel Cell Carcinoma
• Interventions: Drug: INCB099280

• Registration Number: NCT04242199
• Lead Sponsor: Incyte Corporation

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Study Start: 2020-09-04
• Primary Completion: 2024-08-29
• Study Completion: 2024-11-21
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	INCB099280	Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.
Cohort 3	INCB099280	Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy
Cohort 1	INCB099280	Participants with select solid tumors who are immunotherapy treatment-naive

Primary Outcome Measures

Name	Time	Method
Number of treatment-emergent adverse events	Up to approximately 25 months	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.

Secondary Outcome Measures

Name	Time	Method
CL/F of INCB099280	Up to approximately 3 months	Oral dose clearance
tmax of INCB099280	Up to approximately 3 months	Time to maximum plasma concentration
AUC0-t of INCB099280	Up to approximately 3 months	Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t
Vz/F of INCB099280	Up to approximately 3 months	Apparent oral dose volume of distribution
Cmin of INCB099280	Up to approximately 3 months	Minimum observed plasma concentration over the dose interval
λz of INCB099280	Up to approximately 3 months	Terminal elimination rate constant
Cmax of INCB099280	Up to approximately 3 months	Maximum observed plasma concentration
t½ of INCB099280	Up to approximately 3 months	Apparent terminal-phase disposition half-life

Trial Locations

Locations (21)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Upmc Cancercenter; 🇺🇸 Pittsburgh, Pennsylvania, United States

Md Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

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, Australia

Cliniques Universitaires Ucl Saint-Luc; 🇧🇪 Brussels, Belgium

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