KHK2455 Alone and in Combination With Mogamulizumab in Subjects With Locally Advanced or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02867007|
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Cancer Carcinoma||Drug: KHK2455 Drug: Mogamulizumab||Phase 1|
The study is designed as a 2-part, multicenter, open-label, Phase 1, dose-escalation, cohort-expansion study of KHK2455 as a monotherapy run-in (Cycle 0) followed by combination therapy with the anti-CCR4 antibody mogamulizumab (Cycle 1 and beyond).
Part 1 will identify the MTD or the highest protocol-defined dose, in the absence of exceeding the MTD, for the KHK2455 monotherapy run-in and for the combination regimen (KHK2455 monotherapy [Cycle 0] followed by KHK2455 + mogamulizumab combination [Cycle 1]). The dose escalation phase (Part 1) will enroll up to approximately 36 subjects.
Part 2, the cohort-expansion phase, will further explore the safety, tolerability, PK, PD, pharmacogenomics (PGx), and preliminary anti-tumor activity of KHK2455 administered as monotherapy and in combination with mogamulizumab in subjects with one cohort-specific tumor type. In Part 2, approximately 15 subjects with a selected tumor type will be enrolled and treated with the recommended KHK2455 dose established in Part 1 in combination with mogamulizumab.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open-label, Phase 1, Dose-escalation, Cohort-expansion, First-in-Human Study of KHK2455 Administered as Monotherapy and in Combination With Mogamulizumab in Adult Subjects With Locally Advanced or Metastatic Solid Tumors|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
Experimental: KHK2455 + Mogamulizumab
Part 1 (Dose Escalation Part): Will identify the MTD for the KHK2455 monotherapy run-in and for the combination regimen (KHK2455 monotherapy [Cycle 0] followed by KHK2455 +mogamulizumab combination [Cycle 1]).
Part 2 (Expansion Part): Subjects with a selected tumor type will be enrolled and treated with the recommended dose of KHK2455 established in Part 1 in combination with mogamulizumab.
Other Name: Mogamulizumab: KW-0761
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 2 years ]Safety assessment variables will include all adverse events (AEs) including serious and non-serious AEs, changes in clinical laboratory parameters, vital signs, 12-lead electrocardiograms, physical examination, and immunogenicity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867007
|Contact: Kyowa Kirin Pharmaceutical Development, Inc.||firstname.lastname@example.org|
|United States, Florida|
|Tampa, Florida, United States, 33612|
|United States, New Mexico|
|Albuquerque, New Mexico, United States, 87106|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Paris, Villejuif, France, 94800|