Shiyao Group (01093): Phase I clinical study data of SYS6002 monotherapy for the treatment of advanced cervical cancer was announced in the form of a quick oral report on IGCS2026

Zhitong Finance App News, Shiyao Group (01093) announced that at the 2026 Global Annual Meeting of the International Society of Gynecological Oncology (IGCS 2026), the Group announced the data of the Phase I clinical study of SYS6002 monotherapy for the treatment of advanced cervical cancer (this study) in the form of a quick oral report.

The study is a national multi-center phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and initial efficacy of SYS6002 in patients with advanced solid tumors. At this conference, the Group announced the trial results of SYS6002 as a single agent to treat previously treated advanced cervical cancer.

As of May 8, 2026, a total of 82 patients were enrolled in the study and assigned to two dosage groups, including 39 cases in the 2.4 mg/kg dose group every 2 weeks and 43 cases in the 3.6 mg/kg dose group every 3 weeks. The median follow-up time was 16.1 months. The relevant safety and efficacy data are as follows:

In terms of safety, the safety of the above two dosage groups is generally manageable, and treatment-related adverse events are mostly grade 1-2. Among them, ocular adverse events were the most common, but there were no grade 3 or above events, and none of the cases were discontinued as a result. The incidence of interstitial lung disease and non-infectious pneumonia was low (2.4%), the incidence and grade of treatment-related rash was low (any grade: 20.7%; grade 3 and above: 1.2%), and no cases of Stevens-Johnson syndrome or toxic epidermal necrolysis. The incidence and grade of peripheral neuropathy was also low (12.2%; both grade 1-2). Furthermore, there were no treatment-related adverse events leading to death.

In terms of efficacy, both dosage regimens showed initial efficacy in the study population. The confirmed objective response rate for the 2.4 mg/kg dose group was 35.9%, and the confirmed objective response rate for the 3.6 mg/kg dose group every 3 weeks was 28.6%. The median duration of remission in the two groups of patients who achieved confirmed remission was 8.2 months and 10.3 months, respectively; median progression-free survival was 4.1 months and 4.3 months, respectively; and the median overall survival was 15.1 months and 11.5 months, respectively.

Currently, the study of SYS6002 2.4 mg/kg dosing regimen every 2 weeks for immunotherapy of advanced cervical cancer has entered phase III clinical trials (NCT07230626).