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

NCT04242199 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: INCB 99280-1122019-004967-35
• Study Type: interventional
• Target: 182
• Locations: 5 countries
• Sites: 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

Keywords

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Cmax of INCB099280

  Up to approximately 3 months

• tmax of INCB099280

  Up to approximately 3 months

• Cmin of INCB099280

  Up to approximately 3 months

• AUC0-t of INCB099280

  Up to approximately 3 months

• t½ of INCB099280

  Up to approximately 3 months

Study Arms (3)

Cohort 1

EXPERIMENTAL

Participants with select solid tumors who are immunotherapy treatment-naive

Drug: INCB099280

Cohort 2

EXPERIMENTAL

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

Drug: INCB099280

Cohort 3

EXPERIMENTAL

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

Drug: INCB099280

Interventions

INCB099280 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 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (21)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Upmc Cancercenter

Pittsburgh, Pennsylvania, 15232, United States

Location

Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Chris Obrien Lifehouse

Camperdown, New South Wales, 02050, Australia

Location

Austin Hospital

Heidelberg, Victoria, 03084, Australia

Location

Nucleus Network Pty Ltd

Melbourne, Victoria, 03004, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 06009, Australia

Location

Cliniques Universitaires Ucl Saint-Luc

Brussels, 01200, Belgium

Location

Institut Jules Bordet Clinical Trials Conduct Unit

Brussels, B-1070, Belgium

Location

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, 02650, Belgium

Location

Ghent University Hospital

Ghent, 09000, Belgium

Location

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, 03000, Belgium

Location

Institut de Cancerologie de L Ouest - Site Paul Papin

Angers, 49000, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Chu Hopital de La Timone

Marseille, 13385, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

National Cancer Center Hospital East

Chiba, 277-8577, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Uterine Cervical Neoplasms; Carcinoma, Hepatocellular; Esophageal Squamous Cell Carcinoma; Carcinoma, Merkel Cell; Small Cell Lung Carcinoma; Mesothelioma; Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Carcinoma, Squamous Cell; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenoma; Neoplasms, Mesothelial; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study consists of 2 parts. Part 1 is a dose-escalation design to identify the maximum tolerant dose and/or pharmacologically active dose for INCB099280. Part 2 is an expansion at 1 or more dose levels to further explore safety, preliminary efficacy, pharmacokinetic, and pharmacodynamic effects.

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: September 4, 2020
• Primary Completion: August 29, 2024
• Study Completion: November 21, 2024
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2); FR (5); AU (4); BE (5); US (5)