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

Completed · Phase 1

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT04242199

Run by

Incyte Corporation

People needed

182

Starts

2020-09-04

Expected to finish

2024-11-21

Last updated by the study team

2025-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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