Clinical Trials /

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

NCT04272034

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: INCB 99318-122
  • NCT ID: NCT04272034

Conditions

  • 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)

Interventions

DrugSynonymsArms
INCB099318Cohort 1

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Cohort 1ExperimentalParticipants with select solid tumors who are immunotherapy treatment-naive
  • INCB099318
Cohort 2ExperimentalParticipants with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR) tumors who are immunotherapy treatment-naïve.
  • INCB099318
Cohort 3ExperimentalParticipants with progression of any solid tumor treated with an approved anti-PD-1 monoclonal antibody therapy
  • INCB099318

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.

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of treatment-emergent adverse events
Time Frame:Up to approximatley 25 months
Safety Issue:
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.

Secondary Outcome Measures

Measure:Cmax of INCB099318
Time Frame:Up to approximately 3 months
Safety Issue:
Description:Maximum observed plasma concentration
Measure:tmax of INCB099318
Time Frame:Up to approximately 3 months
Safety Issue:
Description:Time to maximum plasma concentration
Measure:Cmin of INCB099318
Time Frame:Up to approximately 3 months
Safety Issue:
Description:Minimum observed plasma concentration over the dose interval
Measure:AUC0-t of INCB099318
Time Frame:Up to approximately 3 months
Safety Issue:
Description:Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t
Measure:t½ of INCB099318
Time Frame:Up to approximately 3 months
Safety Issue:
Description:Apparent terminal-phase disposition half-life
Measure:λz of INCB099318
Time Frame:Up to approximately 3 months
Safety Issue:
Description:Terminal elimination rate constant
Measure:CL/F of INCB099318
Time Frame:Up to approximately 3 months
Safety Issue:
Description:Oral dose clearance
Measure:Vz/F of INCB099318
Time Frame:Up to approximately 3 months
Safety Issue:
Description:Apparent oral dose volume of distribution

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Advanced solid tumors

Last Updated

June 7, 2021