Back to resultsSafety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
Primary Purpose
Advanced Solid Tumor, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
INCB099280
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumor focused on measuring Advanced Solid Tumor
Eligibility Criteria
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.
Sites / Locations
- Dana Farber Cancer Institute
- Henry Ford HospitalRecruiting
- Upmc Cancercenter
- Md Anderson Cancer Center
- University of WashingtonRecruiting
- Chris Obrien LifehouseRecruiting
- Austin Hospital
- Nucleus Network Pty Ltd
- Linear Clinical ResearchRecruiting
- Cliniques Universitaires Ucl Saint-LucRecruiting
- Institut Jules Bordet Clinical Trials Conduct UnitRecruiting
- Universitair Ziekenhuis Antwerpen (Uza)Recruiting
- Ghent University HospitalRecruiting
- Universitaire Ziekenhuis Leuven - Gasthuisberg
- Institut de Cancerologie de L Ouest - Site Paul PapinRecruiting
- Institut BergonieRecruiting
- Chu Hopital de La TimoneRecruiting
- Centre Eugene MarquisRecruiting
- Institut Gustave RoussyRecruiting
- National Cancer Center Hospital EastRecruiting
- National Cancer Center HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
Participants with select solid tumors who are immunotherapy treatment-naive
Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.
Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cmax of INCB099280
Maximum observed plasma concentration
tmax of INCB099280
Time to maximum plasma concentration
Cmin of INCB099280
Minimum observed plasma concentration over the dose interval
AUC0-t of INCB099280
Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t
t½ of INCB099280
Apparent terminal-phase disposition half-life
λz of INCB099280
Terminal elimination rate constant
CL/F of INCB099280
Oral dose clearance
Vz/F of INCB099280
Apparent oral dose volume of distribution
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04242199
Brief Title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
Official Title
A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
203 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Participants with select solid tumors who are immunotherapy treatment-naive
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Participants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Participants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy
Intervention Type
Drug
Intervention Name(s)
INCB099280
Intervention Description
INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle
Primary Outcome Measure Information:
Title
Number of treatment-emergent adverse events
Description
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.
Time Frame
Up to approximately 25 months
Secondary Outcome Measure Information:
Title
Cmax of INCB099280
Description
Maximum observed plasma concentration
Time Frame
Up to approximately 3 months
Title
tmax of INCB099280
Description
Time to maximum plasma concentration
Time Frame
Up to approximately 3 months
Title
Cmin of INCB099280
Description
Minimum observed plasma concentration over the dose interval
Time Frame
Up to approximately 3 months
Title
AUC0-t of INCB099280
Description
Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t
Time Frame
Up to approximately 3 months
Title
t½ of INCB099280
Description
Apparent terminal-phase disposition half-life
Time Frame
Up to approximately 3 months
Title
λz of INCB099280
Description
Terminal elimination rate constant
Time Frame
Up to approximately 3 months
Title
CL/F of INCB099280
Description
Oral dose clearance
Time Frame
Up to approximately 3 months
Title
Vz/F of INCB099280
Description
Apparent oral dose volume of distribution
Time Frame
Up to approximately 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
globalmedinfo@incyte.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Incyte Medical Monitor
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Completed
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Upmc Cancercenter
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Completed
Facility Name
Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Completed
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Name
Chris Obrien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
02050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
03084
Country
Australia
Individual Site Status
Completed
Facility Name
Nucleus Network Pty Ltd
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
03004
Country
Australia
Individual Site Status
Completed
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
06009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Ucl Saint-Luc
City
Brussels
ZIP/Postal Code
01200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Institut Jules Bordet Clinical Trials Conduct Unit
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Antwerpen (Uza)
City
Edegem
ZIP/Postal Code
02650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
09000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitaire Ziekenhuis Leuven - Gasthuisberg
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Individual Site Status
Completed
Facility Name
Institut de Cancerologie de L Ouest - Site Paul Papin
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Hopital de La Timone
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share data
Learn more about this trial
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
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