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

NCT ID: NCT04242199

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-04
• Study Completion Date: 2024-11-21

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Participants with select solid tumors who are immunotherapy treatment-naive

Group Type: EXPERIMENTAL

INCB099280

Intervention Type: DRUG

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

Cohort 2

Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.

Group Type: EXPERIMENTAL

INCB099280

Intervention Type: DRUG

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

Cohort 3

Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy

Group Type: EXPERIMENTAL

INCB099280

Intervention Type: DRUG

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

Interventions

INCB099280

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Incyte Medical Monitor

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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

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, , Belgium

Institut de Cancerologie de L Ouest - Site Paul Papin

Angers, , France

Institut Bergonie

Bordeaux, , France

Chu Hopital de La Timone

Marseille, , France

Centre Eugene Marquis

Rennes, , France

Institut Gustave Roussy

Villejuif, , France

National Cancer Center Hospital East

Chiba, , Japan

National Cancer Center Hospital

Tokyo, , Japan

Countries

United States; Australia; Belgium; France; Japan

Other Identifiers

2019-004967-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INCB 99280-112

Identifier Type: -

Identifier Source: org_study_id