KHK2455 Alone and in Combination With Mogamulizumab in Subjects With Locally Advanced or Metastatic Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02867007|
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : August 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Cancer Carcinoma||Drug: KHK2455 Drug: Mogamulizumab||Phase 1|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
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)|
|Actual Enrollment :||36 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|
|Actual Primary Completion Date :||December 15, 2019|
|Actual Study Completion Date :||December 15, 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867007
|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|