Starton Therapeutics Doses First Patient In Phase 2a STAR-LLD Study For Relapsed/Refractory Multiple Myeloma, Expands To 6 U.S. Sites

Starton Therapeutics Inc., a clinical-stage biotechnology company focused on transforming standard-of-care therapies through proprietary continuous delivery technologies, announced the dosing of the first patient in its Phase 2a study evaluating STAR-LLD for the treatment of relapsed or refractory multiple myeloma (RRMM).

Jamie Oliver, PharmD., Chief Medical Officer at Starton, explained that STAR-LLD is designed to improve tolerability while ensuring effective delivery of lenalidomide. He noted that the therapy aims to reduce the toxic effects often associated with oral lenalidomide, allowing patients to stay on treatment longer and experience the full therapeutic benefit. Dr. Oliver also highlighted that the Phase 2a study builds on encouraging results from the earlier Phase 1b trial, advancing STAR-LLD toward its next stage of clinical development.

Pedro Lichtinger, Chairman and Chief Executive Officer of Starton, described the dosing of the first patient as a key milestone in the company’s mission to redefine the standard of care in multiple myeloma using its proprietary lenalidomide formulation technology. He stated that the study is expected to generate clinical results demonstrating improved tolerability and efficacy compared with current oral dosing, with the ultimate goal of improving patient outcomes. He added that the expansion of the protocol reflects Starton’s growing momentum and its collaborations with leading clinical research centers nationwide.

The Phase 2 study, conducted through the Sargon Site Network, is expanding from two to six investigational sites across the United States to broaden geographic reach and patient access. The newly activated sites are led by distinguished principal investigators, including Dr. Steven Bettag in Sheboygan, Wisconsin; Dr. Sumit Sawhney in Coral Springs, Florida; Dr. Ghassan Al-Jazayrly in Los Angeles, California; and Dr. Hamdy Mohtaseb in Bullhead City, Arizona. 

The study’s original sites are led by Dr. Nash Gabrail in Canton, Ohio, and Dr. Keith Lerro in Wilson, North Carolina. Dr. Gabrail, the lead investigator, commented that the expansion of STAR-LLD in relapsed and refractory multiple myeloma is exciting, noting that the Phase 1b trial demonstrated positive patient responses with no meaningful hematologic toxicity, improving the overall patient experience.

The study is a randomized dose-escalation trial designed to evaluate the tolerability and efficacy of low-dose lenalidomide in heavily treated multiple myeloma patients. It will compare three doses of continuous subcutaneous infusion using STAR-LLD, combined with dexamethasone and a proteasome inhibitor, to oral lenalidomide (Revlimid®) in the same combination. Initially, the trial will enroll 24 transplant-ineligible patients in their second or later line of therapy, with the potential to expand to a total of 69 patients depending on the tolerability of the selected dose and the observed response rate.