A phase II umbrella clinical trial of advanced salivary gland cancer based on molecular typing.

• DOI: 10.1200/jco.2024.42.16_suppl.e18062
• Publication Date: 2024-06-10T16:55:01Z
• Authors: Dongmei Ji; Yanjing Guo; Xin Liu; Yanan Yang; Youzhou Sang; Guangliang Chen; Shu Dong; Yulong Wang; Xiayun He; Hongmei Ying; Xueguan Lu; Yu Wang; Chaosu Hu; Qinghai Ji; Lu Zhang
• Keywords: Salivary gland cancer

e18062 Background: Salivary gland cancers (SGCs) exhibit high heterogeneity in molecular and genomic characteristics, which provides a basis for targeted therapies of SGCs. Until recently, the gene targets precision therapy drugs mainly included HER2, NTRK, TROP2, androgen-receptor (AR), etc. Herein, we report preliminary result single-center, open-label, phase II umbrella clinical trial evaluating efficacy safety subtype-guided advanced salivary cancer (NCT05924256). Methods: Patients (pts) diagnosed as SGC were recruited into 3 arms according to genetic subtypes. Pts with HER2 mutation/amplification or overexpression (IHC 3+ IHC 2+/ISH+) will be assigned arm 1 receive SHR-A1811(anti-HER2) 4.8 mg/kg i.v. on day each 21-day cycle. AR+ pts 2 rezvilutamide 240mg p.o. qd plus leuprolide 3.75mg s.c. 28-day negative AR SHR-A1921(anti-TROP2) 3.0 4.0 A Simon’s two-stage optimal design was applied arm. The primary endpoint objective response rate (ORR) per RECIST1.1. Secondary endpoints adverse events (AEs), disease control (DCR), progression-free survival (PFS), overall (OS), Results: Between Aug 2, 2023, Jan 21, 2024, 21 enrolled (arm 1/2/3: 9/5/7 pts, respectively). All set. In 1, 6 evaluable unconfirmed ORR DCR accounted 100.0% 100.0%, respectively. most common treatment-related (TRAEs) decreased lymphocyte count, neutrophil appetite (44.4% each). 5 20.0% Rash, alanine aminotransferase increased, aspartate gamma-glutamyltransferase increased (20% each) TRAEs. 3, 33.3% 66.7%, this arm, TRAEs stomatitis vomiting (42.9% Conclusions: This showed promising results acceptable toxicity. Clinical information: NCT05924256 .