Results from an international clinical trial demonstrated that DB-1310, a new antibody-drug conjugate, is showing early signs of effectiveness in patients with advanced solid tumors that have not responded to standard treatments, particularly those with EGFR-mutant non–small cell lung cancer (NSCLC). The research was presented at the 2025 ASCO Annual Meeting (Abstract 3000).
Study Details
Study enrollment remains ongoing, but at the time of data cutoff, 172 patients with advanced solid tumors who had already gone through multiple rounds of standard treatments, such as chemotherapy and targeted therapy, were treated with DB-1310. Among these patients, 108 had NSCLC, 62 of whom had EGFR-mutant NSCLC, and 24 had brain metastases.
In phase I of the trial, which remains ongoing, researchers are evaluating the intravenous administration of DB-1310 at 1.5 to 6.5 mg/kg every 3 weeks to identify the safest and most effective dose. Phase II will evaluate approximately 30 to 40 additional patients with tumor types of interest to assess the drug’s effectiveness in treating various cancers.
Key Findings
In this first-in-human trial, 44% of patients with EGFR-mutated NSCLC saw significant shrinkage in their tumors, and the drug delayed cancer growth for a median of 7 months, leading to a median overall survival of 18.9 months. Across all cancer types in the trial, 31% of patients responded to the treatment, with an average of 5.5 months before the cancer progressed and a median overall survival of 14.4 months. The side effects of DB-1310 were generally reported to be manageable, with the most common being low blood cell counts and nausea.
“On this phase I/IIa trial, DB-1310 has shown real potential as a new treatment option for patients with advanced solid tumors that have progressed after standard therapies,” said lead study author Aaron Lisberg, MD, Assistant Professor of Medicine and a thoracic medical oncologist at the David Geffen School of Medicine at UCLA. “These were patients who were heavily pretreated and whose cancers had become resistant to FDA-approved treatments, yet DB-1310 offered a meaningful extension of life with a very tolerable side-effect profile.”
The researchers say the study’s findings are encouraging, particularly for patients with EGFR-mutant lung cancer, who face limited treatment options after standard therapies fail. Larger studies are needed to confirm the results, but these early data suggest DB-1310 could potentially be a new treatment approach for patients with advanced solid tumors.
Disclosure: The study was sponsored by Duality Biologics. For full disclosures of the study authors, visit coi.asco.org.
