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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: 2018-003796-35
  • NCT ID: NCT03915405
  • NCT Alias:
  • Sponsor: Kyowa Kirin, Inc. - Industry
  • Source: Kyowa Kirin, 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 a modified 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 26, 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; OR Been previously treated with platinum based adjuvant or neo-adjuvant
therapy and relapsed or progressed; OR

- Be platinum-based chemotherapy intolerant or ineligible; OR

- Have progressed during or after treatment with approved PD-1/PD-L1 inhibitors

- Subjects must have a tumor accessible for fresh biopsy at the baseline visit and for
IDO assessment. If current circumstances prohibit the biopsy procedure (e.g.,
temporary hospital protocol restrictions, regulatory or local authority requirements,
etc.) then archived tissue from previous biopsies (fresh frozen tissue < 9 months and
formalin fixed-paraffin embedded [FFPE] block of ≤ 24 months) without intervening
checkpoint inhibitors can substitute for a fresh baseline biopsy;

- 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
Kyowa Research Site USA005
Iowa City, Iowa 52242
United States
Recruiting
Kyowa Research Site USA006
Santa Fe, New Mexico 87505
United States
Recruiting
Kyowa Research Site USA 009
Houston, Texas 77030
United States
Recruiting
Kyowa Research Site USA007
Milwaukee, Wisconsin 53226
United States
Recruiting
Kyowa Research Site ESP002
Barcelona, 08003
Spain
Recruiting
Kyowa Research Site ESP003
Barcelona, 08035
Spain
Recruiting
Kyowa Research Site ESP004
Madrid, 28040
Spain
Recruiting
Kyowa Research Site ESP001
Madrid, 28050
Spain
Recruiting