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

March 21, 2024 updated by: Incyte Corporation

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

203

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Incyte Corporation Call Center (US)
  • Phone Number: 1.855.463.3463
  • Email: medinfo@incyte.com

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 02050
        • Recruiting
        • Chris OBrien Lifehouse
    • Victoria
      • Heidelberg, Victoria, Australia, 03084
        • Completed
        • Austin Hospital
      • Melbourne, Victoria, Australia, 03004
        • Completed
        • Nucleus Network Pty Ltd
    • Western Australia
      • Nedlands, Western Australia, Australia, 06009
        • Recruiting
        • Linear Clinical Research
  • Belgium
      • Brussels, Belgium, 01200
        • Recruiting
        • Cliniques Universitaires Ucl Saint-Luc
      • Brussels, Belgium, B-1070
        • Recruiting
        • Institut Jules Bordet Clinical Trials Conduct Unit
      • Edegem, Belgium, 02650
        • Recruiting
        • Universitair Ziekenhuis Antwerpen (Uza)
      • Ghent, Belgium, 09000
        • Recruiting
        • Ghent University Hospital
      • Leuven, Belgium, 03000
        • Completed
        • Universitaire Ziekenhuis Leuven - Gasthuisberg
  • France
      • Angers, France, 49000
        • Recruiting
        • Institut de Cancerologie de L Ouest - Site Paul Papin
      • Bordeaux, France, 33076
        • Recruiting
        • Institut Bergonié
      • Marseille Cedex 5, France, 13385
        • Recruiting
        • Chu Hopital de La Timone
      • Rennes, France, 35042
        • Recruiting
        • Centre Eugène Marquis
      • Villejuif, France, 94800
        • Recruiting
        • Institut Gustave Roussy
  • Japan
      • Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
      • Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Completed
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Completed
        • Upmc Cancercenter
    • Texas
      • Houston, Texas, United States, 77030
        • Completed
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98195
        • Completed
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Participants with select solid tumors who are immunotherapy treatment-naive
Drug: INCB099280
INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle
Experimental: Cohort 2
Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.
Drug: INCB099280
INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle
Experimental: Cohort 3
Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy
Drug: INCB099280
INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 25 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax of INCB099280
Time Frame: Up to approximately 3 months
Maximum observed plasma concentration
Up to approximately 3 months
tmax of INCB099280
Time Frame: Up to approximately 3 months
Time to maximum plasma concentration
Up to approximately 3 months
Cmin of INCB099280
Time Frame: Up to approximately 3 months
Minimum observed plasma concentration over the dose interval
Up to approximately 3 months
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
Up to approximately 3 months
t½ of INCB099280
Time Frame: Up to approximately 3 months
Apparent terminal-phase disposition half-life
Up to approximately 3 months
λz of INCB099280
Time Frame: Up to approximately 3 months
Terminal elimination rate constant
Up to approximately 3 months
CL/F of INCB099280
Time Frame: Up to approximately 3 months
Oral dose clearance
Up to approximately 3 months
Vz/F of INCB099280
Time Frame: Up to approximately 3 months
Apparent oral dose volume of distribution
Up to approximately 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Incyte Medical Monitor, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2020

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 99280-112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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