NCT01516645

Phase 1 Study of KHK2898 in Subjects With Advanced Solid Tumors

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Solid Tumour

Interventions

Type	Name	Description
DRUG	KHK2898	injection

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2012-01-25
• Last updated: 2017-03-16

Locations

1 site across 1 country: Singapore