Optimal ZG006 Dose for Patients With Advanced Small Cell Lung Cancer
According to results from a phase 2 dose-expansion study, 30 mg of ZG006, a trispecific t-cell engager targeting delta-like ligand (DLL3) and CD3, is preferable to 10 mg among patients with advanced small cell lung cancer (SCLC).
These data were first presented by Xinghao Ai, MD, Shanghai Chest Hospital, Shanghai, China, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
In this open-label study, 40 patients who experienced disease progression after at least 2 prior lines of standard systemic therapy were randomized on a 1-to-1 basis to receive either 10 mg (n = 19) or 30 mg (n = 21) of ZG006 once every 2 weeks, with a priming dose of 1 mg. The primary end point was objective response rate (ORR). Key secondary end points included disease control rate and safety.
At analysis, the overall ORR was 66.7% and the overall disease control rate was 92.6%. The ORR was 53.8% in the 10 mg arm and 78.6% in the 30 mg arm. The disease control rate was 84.6% in the 10 mg arm and 100% in the 30 mg arm. Among patients with medium or low baseline DLL3 expression (n = 27) there were 15 partial responses and an ORR of 71.4%.
Treatment-related adverse events were reported in 35 patients and most frequently included pyrexia (57.5%), cytokine release syndrome (47.5%), vomiting (27.5%), rash (25%), decreased appetite (25%), aspartate aminotransferase increase (22.5%), white blood cell count decrease (22.5%), and platelet count decrease (22.5%). Grade 3/4 treatment-related adverse events were reported in 5 patients and included 1 incidence of grade 3 cytokine release syndrome. Serious treatment-related adverse events were reported in 5 patients. Treatment-related adverse events did not lead to treatment discontinuation or death.
“ZG006 exhibited promising efficacy and acceptable safety in SCLC pts receiving ≥ 2 lines of prior treatment, even in pts with low DLL3 expression,” concluded Dr Ai et al. “The enrollment of ZG006-002 study is ongoing.”
Source:
Ai X, Zhang YY, Zhang T, et al. A phase 2 dose expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced small cell lung cancer. Presented at 2025 ASCO Annual Meeting. May 30-June 3, 2025; Chicago, IL. Abstract 8007
