Phase 1 Study of KHK2898 in Subjects With Advanced Solid Tumors
This is a two-part, Phase 1 open label, single-center, dose escalation study of KHK2898 as monotherapy in subjects with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1, Open-Label, Dose Escalation Study of Anti-CD98 Monoclonal Antibody KHK2898 as Monotherapy in Subjects With Advanced Solid Tumors Who No Longer Respond to Standard Therapy or For Whom No Standard Therapy Is Available|
- Adverse Event collection and assessment [ Time Frame: at least 28 days or up to 24 weeks ] [ Designated as safety issue: Yes ]Adverse Event collection and assessment will be done for all 54 potentially treated subjects to assess the safety, tolerability, and determine the DLTs, maximum tolerated dose (MTD).
- Evaluate preliminary evidence of efficacy [ Time Frame: eight weeks ] [ Designated as safety issue: No ]Response and progression in subjects with solid tumors and measurable disease will be evaluated using RECIST criteria v 1.1. Evaluations will include: objective response (CR + PR) and clinical benefit (CR + PR + SD).
- Profile of Pharmacokinetics [ Time Frame: Pre-dose, 1, 2, 4, 6-8, 24, 48, 72, 96, 168, 240-288, 336 hours post-dose ] [ Designated as safety issue: No ]maximum concentration (Cmax), area under the curve (AUC), half-life (t1/2), clearance (Cl), and apparent volume of distribution in the terminal elimination phase (Vz).
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
The study will be conducted in two parts. In Part 1, a standard 3+3 designed dose escalation phase, subjects will receive KHK2898, administered intravenously, once every 2 weeks. A treatment cycle will consists of total of two doses per cycle. Part 2 of the study will enroll subjects with squamous cell type tumor to receive KHK2898 at a dose to be determined following completion of Part 1.
All subjects will receive study therapy until disease progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the subject, or Investigator decision, up to a maximum of six cycles (approximately six months). After six cycles of KHK2898 therapy, the subject may continue to receive the drug after discussion with the Sponsor and determination that the subject is experiencing a best response of at least stable disease (SD) and is not experiencing any unacceptable toxicities or dose limiting toxicities (DLTs).