Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

February 14, 2024 updated by: Incyte Corporation

A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

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
  • Phone Number: 1.855.463.3463
  • Email: medinfo@incyte.com

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, B-1070
        • Institut Jules Bordet
      • Brussels, Belgium, 01090
        • Universitair Ziekenhuis Brussel
      • Edegem, Belgium, 02650
        • Universitair Ziekenhuis Antwerpen (UZA)
      • Ghent, Belgium, 09000
        • Ghent University Hospital
      • Leuven, Belgium, 03000
        • Universitaire Ziekenhuis Leuven - Gasthuisberg
  • Denmark
      • Copenhagen, Denmark, 02100
        • Rigshospitalet Uni of Hospital of Copenhagen
  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital
      • Helsinki, Finland, 00180
        • Docrates Cancer Center
      • Tampere, Finland, 33520
        • Tampere University Hospital
      • Turku, Finland, 20520
        • Turku University Hospital
  • Norway
      • Bergen, Norway, 05051
        • Haukeland University Hospital
      • Oslo, Norway, 00450
        • Oslo University Hospital
  • Sweden
      • Goteborg, Sweden, 41345
        • Sahlgrenska University Hospital
      • Solna, Sweden, 17164
        • Karolinska University Hospital Solna
      • Uppsala, Sweden, 75185
        • Uppsala Universitet - Akademiska Sjukhuset
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust - Hammersmith Hospital
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas Nhs Foundation Trust
      • London, United Kingdom, SM2 5PT
        • The Royal Marsden Hospital Nhs Trust London
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Cancer Institute Faris
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center

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

16 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.
  • ECOG performance status score of 0 or 1.
  • Life expectancy > 12 weeks.
  • Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

Exclusion Criteria:

  • Laboratory values outside the Protocol-defined ranges.
  • Clinically significant cardiac disease.
  • History or presence of an ECG 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 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: INCB099318
INCB099318 administered orally in 20 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: INCB099318
INCB099318 administered orally in 20 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: INCB099318
INCB099318 administered orally in 20 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 INCB099318
Time Frame: Up to approximately 3 months
Maximum observed plasma concentration
Up to approximately 3 months
tmax of INCB099318
Time Frame: Up to approximately 3 months
Time to maximum plasma concentration
Up to approximately 3 months
Cmin of INCB099318
Time Frame: Up to approximately 3 months
Minimum observed plasma concentration over the dose interval
Up to approximately 3 months
AUC0-t of INCB099318
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 INCB099318
Time Frame: Up to approximately 3 months
Apparent terminal-phase disposition half-life
Up to approximately 3 months
λz of INCB099318
Time Frame: Up to approximately 3 months
Terminal elimination rate constant
Up to approximately 3 months
CL/F of INCB099318
Time Frame: Up to approximately 3 months
Oral dose clearance
Up to approximately 3 months
Vz/F of INCB099318
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: Louis Viviers, MD, 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)

March 26, 2021

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

June 20, 2026

Study Registration Dates

First Submitted

February 13, 2020

First Submitted That Met QC Criteria

February 13, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 99318-122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to patient level data is not available for this study

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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