A Phase 1 Study of MORAb-004 in Patients With Solid Tumor (Study: MORAb-004-J081-103)

PHASE1CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

July 31, 2016

Study Completion Date

October 31, 2016

Conditions
Solid Tumor
Interventions
DRUG

MORAb-004

"MORAb-004 5 mg/mL is administered as an intravenous infusion (IV) in an escalating dose design and will not be escalated or de-escalated in individual participants.~Part 1 (Dose escalation): 4 weekly administrations of 2, 4, 8, and 12 mg/kg in four different cohorts on Days 1, 8, 15, and 22 of a 4-week cycle (28 days).~Part 2 (Cohort expansion): 4 and 8 mg/kg on Days 1, 8, 15, and 22 of a 4-week cycle (28 days) and 12 mg/kg biweekly administration on Days 1 and 15 of a 4-week cycle in different cohorts. The dosages in Part 2 can be amended considering the results of Part 1."

Trial Locations (4)

Unknown

Chikusa-ku

Kashiwa

Nagaizumi-cho

Chuo-ku

All Listed Sponsors
lead

Eisai Co., Ltd.

INDUSTRY

NCT01773434 - A Phase 1 Study of MORAb-004 in Patients With Solid Tumor (Study: MORAb-004-J081-103) | Biotech Hunter | Biotech Hunter