MRG002-006: A multicenter phase II clinical trial of MRG002-ADC for unresectable locally advanced or metastatic urothelial cancer.

作者：Wang Qu, Cheng Fu, Weiqing Han, Yongkun Sun, Jizhong Quan, Lijun Chen, Hong Luo, Hailong Hu, Yinong Niu, Danfeng Xu, Yong Liao, Minfeng Chen, Chang-Lu Hu, Yongda Liu, Jimin Chen, Lian Liu, Benkang Shi, Guojun Chen, Fangjian Zhou, Aiping Zhou · 发表于：Journal of Clinical Oncology · 年份：2022 · DOI：10.1200/jco.2022.40.16_suppl.4570 · 被引用次数：7 · 研究领域：Bladder and Urothelial Cancer Treatments、Cancer Immunotherapy and Biomarkers、Esophageal Cancer Research and Treatment

4570 Background: Overexpression of HER-2 is associated with poor prognosis of urothelial cancer, and anti-HER-2 antibody-drug conjugate (ADC) has shown a promising efficacy among the UC patients (pts) in recently studies. MRG002 is a novel HER2-targeted ADC being investigated in the MRG002-006 trial to evaluate the efficacy and safety in HER2 positive UC pts. Methods: This is a single-arm, multicenter phase II study. Eligibility criteria included: histologically HER2-positive (IHC 2+ or 3+) UC pts confirmed by a central-laboratory, ECOG PS 0-1, prior received ≥1 standard treatment. Approximately 40 pts will be enrolled. In the initial dose finding stage, pts were assigned to receive MRG002 at a dose of 2.6 mg/kg or 2.2 mg/kg administered by intravenous infusion every 3 weeks. The dose expanding stage was subsequentially performed based on preliminary results. The primary endpoint was ORR per RECIST 1.1, secondary endpoints are safety, DOR, PFS and, OS. Results: As of December 31, 2021, a total of 39 pts were enrolled. Enrollment is estimated be completed in February 28, 2022, and results are expected to be updated before publication. Nine pts were dosed at 2.6 mg/kg and 26 pts were dosed at 2.2 mg/kg. Based on safety analysis, 2.2 mg/kg was adopted as the recommended dosage. At baseline, 80% pts (28/35) had visceral metastasis. Most pts (28/35) received ≥ 2 lines of treatment and 29 (83%) pts had prior immune checkpoint inhibitor (ICI) therapy. By the cut-off date, 23 pts wer...