Study of IMC-1121B in Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

February 28, 2011

Study Completion Date

February 28, 2011

Conditions
Advanced Solid Tumors
Interventions
BIOLOGICAL

IMC-1121B

Cycle 1: Upon completion of enrollment criteria confirmed at screening, the first dose of study medication should be administered within 7 days. The infusion will be planned every 2 weeks or every 3 weeks on the same day of the week of the first infusion. Dose escalation to Cohort 2 may occur in the absence of a dose-limiting toxicity (DLT) in the first three participants treated in Cohort 1 during the initial 6-week dosing period (Cycle 1). The same procedure will be followed for dose escalation from Cohort 2 to Cohort 3. If 1 of 3 participants in any cohort experiences a DLT in the first 6 weeks (Cycle 1), 3 additional participants will be enrolled in that cohort. Dose escalation to the next cohort may occur if less that 2 of 6 participants experience a DLT during Cycle 1.

Trial Locations (1)

104-0045

ImClone Investigational Site, Tokyo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Eli Lilly and Company

INDUSTRY