Clinical Trials /

KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer

NCT03915405

Description:

This is a two-part (dose-escalation, dose-expansion), multicenter, open-label Phase 1 study of KHK2455 in combination with avelumab in adult subjects with locally advanced or metastatic urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis).

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer
  • Official Title: An Open-label, Phase 1 Study of KHK2455 in Combination With Avelumab in Adult Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: 2455-002
  • NCT ID: NCT03915405

Conditions

  • Urothelial Carcinoma

Interventions

DrugSynonymsArms
KHK2455KHK2455 in Combination with Avelumab
AvelumabKHK2455 in Combination with Avelumab

Purpose

This is a two-part (dose-escalation, dose-expansion), multicenter, open-label Phase 1 study of KHK2455 in combination with avelumab in adult subjects with locally advanced or metastatic urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis).

Detailed Description

      This is a two-part (dose-escalation, dose-expansion), multicenter, open-label Phase 1 study
      of KHK2455 in combination with avelumab in adult subjects with locally advanced or metastatic
      urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis). Subjects will
      be screened for entry into this study after signing informed consent. Subjects must meet
      inclusion/exclusion criteria to participate in this study.

        -  Part 1 (dose-escalation phase) has has a 3+3 design that will evaluate the safety and
           tolerability and identify the MTD or highest protocol-defined dose, in the absence of
           exceeding the MTD.

        -  Part 2 (cohort-expansion phase) will further explore the safety, pharmacokinetics,
           pharmacodynamics, and anti-tumor activity for the combination regimen at the MTD or
           highest dose level tested.
    

Trial Arms

NameTypeDescriptionInterventions
KHK2455 in Combination with AvelumabExperimental
  • KHK2455
  • Avelumab

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects may be male or female and must be ≥ 18 years of age; have an ECOG PS of 0 or
             1; and a life expectancy of > 3 months in the Investigator's judgment;

          -  Subjects are able to understand and willing to sign the ICF, according to
             institutional standards, prior to the initiation of any study related procedures

          -  Subjects must have histological or cytological evidence of metastatic or advanced
             urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis that has
             predominantly transitional cell or urothelial features); and have measurable
             neoplastic disease according to RECIST v1.1 criteria

          -  Subjects must have been previously treated with a platinum-based therapy and
             progressed during or within 12 months of treatment; and be checkpoint-inhibitor naive
             (not treated with agents targeting PD-1, PD-L1 or CTLA-4)

          -  Subjects must have a tumor accessible for fresh biopsy at the baseline visit and for
             subsequent biopsies during the study for IDO assessment. Archived tissue from previous
             biopsies (formalin fixed-paraffin embedded [FFPE] block of <12 months) are permitted
             for PD-L1 analysis

          -  Subjects must be able to swallow the solid (encapsulated) dosage form of KHK2455

        Exclusion Criteria:

          -  Subjects who have been previously treated with avelumab or any IDO1 inhibitor or
             CTLA-4, PD-1/PD-L1 checkpoint inhibitors; or any investigational immunotherapy
             including but not limited to anti-cancer vaccines or oncotropic viruses

          -  Subjects with prior or current liver metastases;

          -  Subjects with a history of organ transplant or allogeneic bone marrow transplant;

          -  Subjects with pre-existing uveitis or other known clinically meaningful retinal
             disorders as determined by a local ophthalmologist
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0
Time Frame:up to 24 months
Safety Issue:
Description:To characterize the safety and tolerability of KHK2455 administered in combination with avelumab in subjects with locally advanced or metastatic urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis).

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Kyowa Kirin Pharmaceutical Development, Inc.

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