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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04272034
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : October 21, 2022
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors MSI-H/dMMR Tumors Cutaneous Squamous Cell Carcinoma Urothelial Carcinoma, HCC Cervical Cancer Esophageal Squamous Cell Carcinoma Merkel Cell Carcinoma Small-cell Lung Cancer Mesothelioma PD-L1 Amplified Tumor (9p24.1) Nasopharyngeal Carcinoma Cyclin-dependent Kinase 12 Mutated Tumors Basal Cell Carcinoma (Unresectable or Metastatic) Sarcomatoid Renal Cell Carcinoma Clear Cell Ovarian or Endometrial Carcinoma Anal Carcinoma Squamous Cell Penile Carcinoma DNA Polymerase Epsilon Mutated Tumors (P286R and V411L) Drug: INCB099318 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study consists of 2 parts. Part 1 is a dose-escalation design to identify the maximum tolerated dose and/or pharmacologically active dose for INCB099318. Part 2 is an expansion at 1 or more dose levels to further explore safety, preliminary efficacy, pharmacoketics, and pharmacodynamic effects.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Select Advanced Solid Tumors
Actual Study Start Date : March 26, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Cmax of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Maximum observed plasma concentration

  2. tmax of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Time to maximum plasma concentration

  3. Cmin of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Minimum observed plasma concentration over the dose interval

  4. 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

  5. t½ of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Apparent terminal-phase disposition half-life

  6. λz of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Terminal elimination rate constant

  7. CL/F of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Oral dose clearance

  8. Vz/F of INCB099318 [ Time Frame: Up to approximately 3 months ]
    Apparent oral dose volume of distribution


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04272034


Contacts
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Contact: Incyte Corporation Call Center 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex US) +800 00027423 globalmedinfo@incyte.com

Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Louis Viviers, MD Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04272034    
Other Study ID Numbers: INCB 99318-122
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: October 21, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to patient level data is not available for this study

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Advanced solid tumors
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Carcinoma
Neoplasms
Carcinoma, Squamous Cell
Carcinoma, Renal Cell
Small Cell Lung Carcinoma
Mesothelioma
Nasopharyngeal Carcinoma
Esophageal Squamous Cell Carcinoma
Carcinoma, Basal Cell
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Uterine Neoplasms
 Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases