Clinical Trials Search
Clinical Trial 18855
Interventions:KHK2455; KW-0761 (Mogamulizumab); Mogamulizumab
Study Type: Treatment
Phase of Study: Phase I
- Solmaz Sahebjam
Multicenter, Open-label, Phase 1, Dose-escalation,Cohort-expansion, First-in-Human Study of KHK2455 Administered as Monotherapy and in Combination with Mogamulizumab (KW-0761) in Adult Subjects with Locally Advanced or Metastatic Solid Tumors
The purpose of this study is to: - Test side effects (safety) of KHK2455 taken in combination with mogamulizumab. - Identify the highest tolerable dose of KHK2455 taken in combination with mogamulizumab that can be given safely. - See if it helps people with locally advanced or metastatic solid tumors.
Primary: -To characterize the safety, tolerability, and determine the maximum tolerated dose (MTD) or the highest protocol-defined dose, in the absence of exceeding the MTD, of KHK2455 administered orally in combination with mogamulizumab to subjects with locally advanced or metastatic solid tumors. Secondary: -To characterize the pharmacokinetic (PK) profile of KHK2455 when administered alone and in combination with mogamulizumab; -To assess the effect of KHK2455 on indoleamine 2,3-dioxygenase (IDO)inhibition (kynurenine/tryptophan ratio) when KHK2455 is administered alone and in combination with mogamulizumab; -To describe any anti-tumor responses when KHK2455 is administered alone and in combination with mogamulizumab. Exploratory: -To assess the effect of KHK2455 on other pharmacodynamic (PD) markers when KHK2455 is administered alone and in combination with mogamulizumab; -To explore PK/PD relationships for anti-tumor response, PD markers, and safety; -To evaluate the effect of KHK2455 on the immunogenicity and serum concentrations of mogamulizumab.