Abstract 857TiP
Background
Phospholipid ethers (PLE) provide an innovative approach to preferentially target cancer cells by capitalizing on their increased number/size of lipid rafts. PLE are designed to possess high affinity to lipid rafts which upon binding results in internalization and the ability to deliver an attached warhead to the cytosol. CLR 131 is a novel PLE conjugated to I-131, which was chosen due to its 8-day half-life and well-established efficacy in multiple cancer types. Preclinical/phase I data has shown CLR 131 to be preferentially taken up by cancer cells and to cross the blood brain barrier.
Trial design
CLOVER-1 is a two-part, non-randomized open-label, multi-center study evaluating the effects of CLR 131 in patients with B-cell malignancies who have failed standard of care treatment for their underlying malignancy. Part A of the study is a phase 2, dose finding clinical study evaluating CLR 131 in patients with B-cell malignancies including MM and various NHL subsets primarily; WM, DLBCL, CLL, MZL and MCL. CLOVER-WaM is a global, pivotal efficacy and safety expansion cohort evaluating CLR 131 in refractory patients with Waldenstrom Macroglobulinemia. Other CLOVER-WaM key inclusion criteria include: ECOG status 0-2, measurable disease (IgM > ULN or measurable lesion) and received at least two prior lines of therapy (including those that have had a sub-optimal response or failed treatment with a BTK inhibitor). This study plans to enroll 50 WM patients who will receive 4 total infusions of CLR 131 (15 mCi/m2) over 2 cycles, each cycle lasting ∼57 days. The primary efficacy endpoint is major response rate while secondary endpoints include treatment free remission, overall survival, progression free survival and safety, among others. This trial is in progress and sites are actively enrolling in the United States, Europe, and Australia. Enrollment is expected to take 18 months.
Clinical trial identification
NCT02952508.
Editorial acknowledgement
Legal entity responsible for the study
Cellectar Biosciences.
Funding
Cellectar Biosciences.
Disclosure
A. Chanan-Khan: Non-Financial Interests, Personal, Member of the Board of Directors: Cellectar Biosciences. J. Longcor, K. Oliver, M.F. Brown, J. Friend: Financial Interests, Personal, Full or part-time Employment: Cellectar Biosciences. All other authors have declared no conflicts of interest.