Starton Therapeutics Opens Enrollment For Phase 2a Trial Of STAR-LLD, A Continuous Low-Dose Lenalidomide Therapy For Multiple Myeloma

Starton Therapeutics Inc., a clinical-stage biotechnology company focused on improving standard-of-care treatments through continuous drug delivery technologies, announced that patient enrollment has begun at Gabrail Cancer Center (GCC) in Canton, Ohio, for its ongoing Phase 2a clinical trial evaluating STAR-LLD in multiple myeloma. Dr. Nash Gabrail, a medical oncologist and founder of the center, is serving as the lead investigator for the study. In addition, the Regional Medical Oncology Center in Wilson, North Carolina, has also opened as a second active site for the trial.

The Phase 2a study builds on data from the recently presented Phase 1b portion of the trial, which Starton shared at the 2025 American Association for Cancer Research (AACR) meeting. The current phase will further assess the safety and tolerability of continuous subcutaneous infusion of low-dose lenalidomide (STAR-LLD) in patients with heavily pretreated multiple myeloma. The investigational therapy will be administered in combination with dexamethasone and a protease inhibitor (PI), and will be compared to the standard oral lenalidomide (Revlimid®) plus dexamethasone and a PI.

Pedro Lichtinger, Chairman and Chief Executive Officer of Starton Therapeutics, mentioned, “We are excited to announce this major milestone in our mission to bring breakthrough therapies to patients. This marks the next phase of development for our lead candidate, STAR-LLD, and represents a significant step forward for the entire team,” 

Dr. Jamie Oliver, Starton’s Chief Medical Officer, stated, “We expect this study to expand on what we observed in our prior Phase 1b study, that continuous low-dose lenalidomide provides meaningful efficacy and improved tolerability

 The expanded cohort and dose escalation will help us determine the most effective dose, with the goal of maintaining acceptable safety and tolerability.”

The trial plans to randomize at least 24 patients to either STAR-LLD or oral lenalidomide. An additional group of up to 45 patients may be enrolled to determine the optimal dosing strategy for a future registrational study, based on overall response rates, dose levels, and incidence of Grade 3–4 toxicities. Starton expects to expand the trial to include approximately 10 clinical sites in total. This trial marks an important step in Starton’s mission to enhance the effectiveness and tolerability of established therapies through innovative drug delivery approaches, with the ultimate goal of improving patient outcomes in multiple myeloma.