Our Clinical Trials

Iopofosine Clinical Studies

Clinical studies are essential to finding new and better treatments. Clinical studies remain a fundamental necessity in the development and advancement of new treatment options for battling cancer, and you could play an important role! Clinical studies require patient enrollment as part of the regulatory process to advance a a new treatment to market. Your participation in clinical studies may help create a better treatment landscape for future cancer patients.

To learn more general information about clinical studies, please visit www.cancer.org and find the "Clinical Studies" section.

Study of Iopofosine I 131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) and Phase 2 Expansion in Waldenström Macroglobulinemia

Part A of this study evaluates iopofosine I 131 (CLR 131) in patients with select B-cell malignancies (multiple myeloma (MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenström macroglobulinemia (WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), diffuse large b-cell lymphoma (DLBCL), and central nervous system lymphoma (CNSL) who have been previously treated with standard therapy for their underlying malignancy.

Part B (CLOVER-WaM) is a Phase 2 pivotal study evaluating IV administration of iopofosine I 131 in patients with r/r WM that have received at least two prior lines of therapy. Primary endpoint is Major Response Rate. Enrollment was completed in 2024 and patients remain in follow-up.

Status
Active, Not Recruiting
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Novel Targeted Radiotherapy in Pediatric Patients with Inoperable Relapsed or Refractory HGG

The Phase 1b is a dose-finding study evaluating the efficacy and safety of 2 different doses and dosing regimens of CLR 131 in children, adolescents, and young adults with relapsed high-grade glioma (HGG). The study follows the Phase 1a where the maximum tolerated dose was determined. Primary endpoint of the Phase 1b is progression free survival.

Status
Active, Not Recruiting
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Study of CLR 225 (Alpha Program)

A Phase 1 dose escalation safety study evaluating CLR 225, an actinium-225 conjugate for targeted alpha therapy in refractory solid tumors is planned to initiate in 2026. This study will determine biodistribution via dosimetry and maximum tolerated single and multiple ascending doses of CLR 225 in patients. Primary endpoint is determination of the maximum safe dose.

Status
Planned Phase 1

Study of CLR 125 (Auger Program)

Phase 1b Study to demonstrate biodistribution via dosimetry and to evaluate three different doses and dosing regimens of CLR 125 an Auger electron–emitting phospholipid ether conjugate, to determine the recommended Phase 2 dose. The study will be conducted in patient with relapsed triple negative breast cancer. Primary endpoint is object response via RECIST 1.0. )

Status
Active, Not Recruiting

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