Skip to main content
OpenTrials
Completed

NCT Number: NCT04242199

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Solid Tumor Adenocarcinoma Adenoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Carcinoma, Squamous Cell Carcinoma, Transitional Cell Cervical Cancer Cutaneous Squamous Cell Carcinoma DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Hepatocellular Carcinoma Infections Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms MSI-H/dMMR Tumors Merkel Cell Carcinoma Mesothelioma Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms PD-L1 Amplified Tumor (9p24.1) Pharyngeal Diseases Pharyngeal Neoplasms Polyomavirus Infections Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Small-cell Lung Cancer Stomatognathic Diseases Thoracic Neoplasms Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Urothelial Carcinoma Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chris Obrien Lifehouse, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Number of treatment-emergent adverse events

    Time frame: 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 outcomes

  1. Cmax of INCB099280

    Time frame: Up to approximately 3 months

    Maximum observed plasma concentration

  2. tmax of INCB099280

    Time frame: Up to approximately 3 months

    Time to maximum plasma concentration

  3. Cmin of INCB099280

    Time frame: Up to approximately 3 months

    Minimum observed plasma concentration over the dose interval

  4. AUC0-t of INCB099280

    Time frame: Up to approximately 3 months

    Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t

  5. t½ of INCB099280

    Time frame: Up to approximately 3 months

    Apparent terminal-phase disposition half-life

  6. λz of INCB099280

    Time frame: Up to approximately 3 months

    Terminal elimination rate constant

  7. CL/F of INCB099280

    Time frame: Up to approximately 3 months

    Oral dose clearance

  8. Vz/F of INCB099280

    Time frame: Up to approximately 3 months

    Apparent oral dose volume of distribution

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2020
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.