NCT01469975 - First in Man Study Investigating the Biodistribution, the Safety and Optimal Recommended Dose of a New Radiolabelled Monoclonal Antibody Targeting Frizzled Homolog 10 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

February 3, 2015

Study Completion Date

June 30, 2015

Conditions

Sarcoma, Synovial

Interventions

DRUG

OTSA101-DTPA-90Y level 1

Part 2 of the study 1.5 mg of OTSA101-DTPA radiolabelled with 370MBq of 90Y will be administered IV as a single injection on Day 0.

DRUG

OTSA101-DTPA-90Y level 2

Part 2 of the study 1.5 mg of OTSA101-DTPA radiolabelled with 1110 MBq of 90Y will be administered IV as a single injection on Day 0.

DRUG

OTSA101-DTPA-90Y level 3

"Part 2 of the study 3 mg of OTSA101-DTPA radiolabelled with 2220 MBq of 90Y will be administered IV as a single injection on Day 0.~This third dose level evaluation will be based on safety and preliminary efficacy data."

Trial Locations (1)

69373

Centre Léon Bérard, Lyon