Clinical Trials /

A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Solid Tumors

NCT03522142

Description:

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of single-agent INCB081776 (Part 1) and INCB081776 in combination with nivolumab (Part 2).

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Solid Tumors
  • Official Title: A Phase 1a/1b Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: INCB 81776-101
  • NCT ID: NCT03522142

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
INCB081776INCB081776
NivolumabOPDIVO®INCB081776 + Nivolumab

Purpose

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of single-agent INCB081776 (Part 1) and INCB081776 in combination with nivolumab (Part 2).

Trial Arms

NameTypeDescriptionInterventions
INCB081776ExperimentalSingle-agent INCB081776.
  • INCB081776
INCB081776 + NivolumabExperimentalINCB081776 in combination with nivolumab.
  • INCB081776
  • Nivolumab

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.

          -  Must have received or been intolerant to standard therapy.

          -  Eastern Cooperative Oncology Group performance status score of 0 or 1.

          -  Willingness to avoid pregnancy or fathering children as per protocol-defined criteria.

        Exclusion Criteria:

          -  Laboratory values not within the protocol-defined range.

          -  History of retinal disease as defined in the protocol.

          -  Clinically significant cardiac disease as per protocol-defined criteria.

          -  History or presence of an ECG that, in the investigator's opinion, is clinically
             meaningful as per protocol-defined criteria.

          -  Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases
             that have progressed as per protocol-defined criteria.

          -  Active or inactive autoimmune disease or syndrome that has required systemic treatment
             in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory
             disease.

          -  Prior Grade 3 or higher immune-related AEs or any ocular toxicity on prior
             immunotherapy as per protocol-defined criteria.

          -  Receipt of any vitamin K antagonists, systemic corticosteroids, live vaccines, or
             treatment with any anticancer medications or investigational drugs within the
             protocol-defined intervals.

          -  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.

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

Primary Outcome Measures

Measure:Part 1: Identification of a pharmacologically active dose (PAD) and/or maximum tolerated dose (MTD) (whichever is lower) of INCB081776
Time Frame:Up to 12 months
Safety Issue:
Description:To establish a PAD and/or MTD of INCB081776 for further investigation in participants with advanced solid tumors who have failed prior treatments.

Secondary Outcome Measures

Measure:Part 1 and Part 2: Cmax of INCB081776
Time Frame:Up to approximately 3 weeks.
Safety Issue:
Description:Maximum observed plasma or serum concentration.
Measure:Part 1 and Part 2: Tmax of INCB081776
Time Frame:Up to approximately 3 weeks.
Safety Issue:
Description:Time to maximum concentration.
Measure:Part 1 and Part 2: t½ of INCB081776, which will be summarized
Time Frame:Up to approximately 3 weeks.
Safety Issue:
Description:Apparent terminal-phase disposition half life.
Measure:Part 1 and Part 2: Pharmacokinetic/ pharmacodynamic correlation of AXL inhibition
Time Frame:Up to approximately 3 weeks.
Safety Issue:
Description:To evaluate the pharmacodynamics of INCB081176 as determined by target inhibition of AXL in participants with advanced solid tumors.
Measure:Part 1 and Part 2: Overall response rate
Time Frame:Up to approximately 1 year.
Safety Issue:
Description:Defined as the percentage of participants having complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measure:Part 1 and Part 2: Disease control rate
Time Frame:Up to approximately 1 year.
Safety Issue:
Description:Defined as the percentage of participants having CR, PR, or stable disease (SD) per RECIST v1.1.
Measure:Part 1 and Part 2: Duration of response
Time Frame:Up to approximately 1 year.
Safety Issue:
Description:Defined as the time from earliest date of disease response until the earliest date of disease progression (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

  • Advanced solid tumors
  • AXL
  • MER
  • AXL/MER

Last Updated