An Open-label, Dose-escalation Safety and Tolerability Trial Assessing Multiple Dose Administrations of Anti-KIR (1-7F9) Human Monoclonal Antibody in Subjects With Multiple Myeloma
Trial Design:
The trial is an open-label, dose-escalation trial to determine the safety and tolerability
of Anti-KIR (1-7F9) in subjects with relapsed or refractory multiple myeloma (RRMM). A 3+3
design will be employed for the first dosing cycle at each dose level. The 7 planned dose
levels are 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg and 3.0
mg/kg. The subjects will receive up to a total of 4 administrations of Anti-KIR (1-7F9) with
a dosing interval between each administration of 4 weeks. Safety, toxicity, PK
(pharmacokinetic) and PD (pharmacodynamic) obtained in the first 4 weeks after dosing per
group will be the basis for dose-escalation decisions. There will be follow-up visits every
week the one month after the first administration and every two weeks following the second,
third and fourth administrations. After the last administration there will be follow-up
visits every month until KIR occupancy is no longer detected.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of IPH2101 as Determined by Number of Participants With Dose-Limiting Toxicities (DLTs) Related to IPH2101 Treatment
The maximum tolerated dose (MTD) is the highest dose level below the maximum administered dose (MAD) where none or 1 out of 6 subjects have a DLT.
From start of the treatment to end of study
Yes
Sherif Farag, MD, PhD
Principal Investigator
Indiana University
United States: Food and Drug Administration
IPH2101-103
NCT00552396
May 2007
January 2011
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Ohio State University Medical Center | Columbus, Ohio 43210 |
Mont Sinai Medical Center | New York City, New York 10029 |
Cancer Therapy Research Center at UTHSCSA | San Antonio, Texas 78229-4427 |