Starton Therapeutics has opened enrollment for its Phase 2a clinical trial evaluating STAR-LLD, a continuous low-dose lenalidomide formulation for multiple myeloma treatment, marking a significant advancement in the company's mission to transform standard-of-care cancer therapies through proprietary continuous delivery technology.
The Gabrail Cancer Center in Canton, Ohio, and Regional Medical Oncology Center in Wilson, North Carolina, have been activated as the first two clinical sites for the trial. Dr. Nash Gabrail, medical oncologist and founder of Gabrail Cancer Center, serves as the study's lead investigator.
Promising Phase 1b Results Drive Advancement
The Phase 2a trial builds on compelling results from Starton's Phase 1b study, which demonstrated that continuous low-dose lenalidomide provides meaningful efficacy with improved tolerability. All six relapsed/refractory multiple myeloma patients who received STAR-LLD achieved objective responses, including one complete response and five partial responses.
Notably, no patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 throughout up to 12 cycles of therapy. The study concluded that continuous delivery of low-dose lenalidomide provides meaningful efficacy and improved tolerability with no grade >2 drug-related hematologic toxicity.
"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," said Dr. Jamie Oliver, Starton's Chief Medical Officer. "The expanded cohort and dose escalation will help us determine the most effective dose, with the goal of maintaining acceptable safety and tolerability."
Preclinical Data Supports Continuous Delivery Approach
Preclinical proof-of-concept studies provided strong rationale for the continuous delivery approach. In animal models, multiple myeloma tumors caused by human myeloma cells grew 25-fold when untreated and five-fold when treated with daily lenalidomide. However, tumors shrank by 80% with STAR-LLD over a single 28-day cycle.
The preclinical study demonstrated a 100% overall response rate using continuous delivery lenalidomide, with 20% of animals achieving tumor-free status after 100 days. This contrasted sharply with a 0% overall response rate in animals treated with a 70% higher dose of lenalidomide administered in single daily doses.
Phase 2a Trial Design and Objectives
The Phase 2a study will assess the safety and tolerability of low-dose lenalidomide in heavily treated multiple myeloma patients. The trial design includes a direct comparison between continuous subcutaneous infusion (STAR-LLD) combined with dexamethasone and a protease inhibitor versus oral lenalidomide (Revlimid®) combined with dexamethasone and a protease inhibitor.
At least 24 patients will be randomized between the two treatment arms. The study may enroll up to 45 additional patients to identify the optimal dose for a future registrational study, based on overall response rate versus dose versus Grade 3-4 toxicity profiles. Starton anticipates opening approximately 10 clinical sites for the trial.
Addressing Unmet Medical Need
STAR-LLD is being developed to expand and potentially replace standard-of-care treatments for multiple myeloma and chronic lymphocytic leukemia, two of the most common blood cancers. The continuous delivery approach aims to increase the efficacy of approved drugs while making them more tolerable and expanding their potential therapeutic applications.
"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," stated Pedro Lichtinger, Chairman and Chief Executive Officer of Starton Therapeutics.
The company recently presented Phase 1b results at the 2025 American Association for Cancer Research, highlighting the clinical potential of their proprietary continuous delivery technology platform.
