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BRIEF TITLE: An Open-label, Phase 1 Study of KHK2455 in Combination With Avelumab in Adult Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

An Open-label, Phase 1 Study of KHK2455 in Combination With Avelumab in Adult Subjects With Locally Advanced or Metastatic Urothelial Carcinoma


  • Org Study ID: 2455-002
  • Secondary ID:
  • NCT ID: NCT03915405
  • NCT Alias:
  • Sponsor: Kyowa Kirin Pharmaceutical Development, Inc. - Industry
  • Source: Kyowa Kirin Pharmaceutical Development, Inc.

Brief Summary

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.

Overal Status Start Date Phase Study Type
Recruiting September 30, 2019 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0

Primary Outcome 1 - Time Frame: up to 24 months

Condition:

  • Urothelial Carcinoma

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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Kyowa Kirin Pharmaceutical Development, Inc.

Phone: 1-609-919-1100

Email: KKD.clinical.info@kyowakirin.com

Locations

Facility Status Contact
Kyowa Research Site USA004
Gilbert, Arizona 85234
United States
Recruiting
Kyowa Research Site USA001
Saint Petersburg, Florida 33709
United States
Recruiting