A Phase I Study to Assess The Safety and Pharmacokinetics of BB-10901 (huN901-DM1) Given as an Intravenous Infusion Weekly for Two Consecutive Weeks Every Three Weeks to Subjects With Relapsed and Relapsed Refractory CD56-Positive Multiple Myeloma
- Determine the dose-limiting toxicity and the maximum tolerated dose of BB-10901 in
patients with relapsed and/or refractory CD56-positive multiple myeloma.
- To determine the qualitative and quantitative toxicities of BB-10901 administered on
- To evaluate the pharmacokinetics of BB-10901.
- To recommend a dose for Phase II clinical studies with BB-10901 given on this specific
- To observe any evidence of anti-tumor activity with BB-10901.
Objectives of MTD Expansion Cohort
- To evaluate response rate including overall response rate (ORR) and complete response
rate (CRR), and duration of response (DOR).
- To further assess time to progression (TTP), progression free survival (PFS), and
overall survival (OS).
OUTLINE: This is an open-label, non-randomized, dose-escalation, multicenter study.
Patients receive BB-10901 IV over 1-2 hours on days 1 and 8. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BB-10901 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. Up to 40 patients are treated at the MTD.
After completion of study treatment, patients are followed for short term follow-up and long
term (up to 3 years) survival status.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
through cycle 1
Asher Alban Akmal Chanan-Khan,, M.D.
Roswell Park Cancer Institute
United States: Food and Drug Administration
|UCSF||San Francisco, California 941430324|
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|St. Vincent's Comprehensive Cancer Center - Manhattan||New York, New York 10011|
|Cedars-Sinai Outpatient Cancer Center||Los Angeles, California|