Clinical Trials /

A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

NCT03762447

Description:

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors
  • Official Title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: INCB 86550-102
  • NCT ID: NCT03762447

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
INCB086550INCB086550

Purpose

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments.

Trial Arms

NameTypeDescriptionInterventions
INCB086550Experimental
  • INCB086550

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed advanced solid tumors with measurable lesions per RECIST v1.1
             that are considered nonamenable to surgery or other curative treatments or procedures.
             Tumor lesions located in a previously irradiated area, or in an area subjected to
             other loco-regional therapy, are considered measurable if progression has been
             demonstrated in the lesion.

          -  Must have disease progression after treatment with available therapies that are known
             to confer clinical benefit or who are intolerant to or ineligible for standard
             treatment. There is no limit to the number of prior treatment regimens.

          -  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 not within the Protocol-defined range.

          -  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. Participants who have previously treated and clinically stable
             brain or CNS metastases and have not required steroids for at least 7 days before
             study treatment are eligible.

          -  Known additional malignancy that is progressing or requires active treatment.

          -  Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy and/or
             complications from prior surgical intervention before starting study treatment.

          -  Treatment with anticancer medications or investigational drugs within protocol-defined
             intervals before the first administration of study drug.

          -  Active infection requiring systemic therapy.

          -  Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

          -  Known history of HIV (HIV 1/2 antibodies).

          -  Known hypersensitivity or severe reaction to any component of study drug or
             formulation components.
      
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:Baseline through 90 days after end of treatment, estimated up to 12 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.

Secondary Outcome Measures

Measure:Cmax of INCB086550
Time Frame:Approximately 1 month
Safety Issue:
Description:Maximum observed plasma or serum concentration.
Measure:tmax of INCB086550
Time Frame:Approximately 1 month
Safety Issue:
Description:Time to maximum concentration.
Measure:Cmin of INCB086550
Time Frame:Approximately 1 month
Safety Issue:
Description:Minimum observed plasma or serum concentration over the dose interval.
Measure:AUC0-t of INCB086550
Time Frame:Approximately 1 month
Safety Issue:
Description:Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Measure:t½ of INCB086550
Time Frame:Approximately 1 month
Safety Issue:
Description:Apparent terminal-phase disposition half-life.
Measure:λz of INCB086550
Time Frame:Approximately 1 month
Safety Issue:
Description:Apparent terminal-phase disposition rate constant
Measure:CL/F of INCB086550
Time Frame:Approximately 1 month
Safety Issue:
Description:Apparent oral dose clearance.
Measure:Vz/F of INCB086550
Time Frame:Approximately 1 month
Safety Issue:
Description:Apparent oral dose volume of distribution.
Measure:Pharmacokinetic/pharmacodynamics association of INCB086550 exposure with expression levels of PD-L1
Time Frame:Approximately 1 month
Safety Issue:
Description:Evaluation of the ability of INCB086550 to modulate PD-L1 expression levels as assessed by flow cytometry protein analyses.
Measure:Objective response rate
Time Frame:Every 8 weeks for the duration of study participation; estimated to be 12 months.
Safety Issue:
Description:Defined as the percentage of participants having complete response (CR) or partial response (PR) by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measure:Disease control rate
Time Frame:Every 8 weeks for the duration of study participation; estimated to be 12 months.
Safety Issue:
Description:Defined as the percentage of participants having CR, PR, or stable disease ≥ 12 weeks by investigator assessment of radiographic disease assessments per RECIST v1.1.
Measure:Duration of response
Time Frame:Every 8 weeks for the duration of study participation; estimated to be 12 months.
Safety Issue:
Description:Defined as the time from the first documented evidence of CR or PR until the earliest date of disease progression by investigator assessment per RECIST v1.1 or death due to any cause, if occurring sooner than progression.

Details

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

Trial Keywords

  • solid tumors

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