CSPC Pharma (01093) has announced that the company presented Phase I clinical trial data for SYS6002 monotherapy in the treatment of advanced cervical cancer as a rapid oral presentation at the 2026 International Gynecologic Cancer Society Global Annual Meeting (IGCS 2026).

The study is a nationwide multicenter Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of SYS6002 in patients with advanced solid tumors. At this conference, the company reported results from the trial of SYS6002 monotherapy in previously treated advanced cervical cancer.

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

In terms of safety, the overall safety profiles of both dose groups were manageable, with treatment-related adverse events mostly Grade 1–2. Ocular-related adverse events were the most common, but no Grade 3 or above events occurred, and no patient discontinued treatment due to such events. The incidence of interstitial lung disease and non-infectious pneumonia was low (2.4%), and the incidence and severity of treatment-related rash were both low (any grade: 20.7%; Grade 3 or above: 1.2%), with no cases of Stevens-Johnson syndrome or toxic epidermal necrolysis. The incidence and severity of peripheral neuropathy were also low (12.2%; all Grade 1–2). In addition, no treatment-related adverse events leading to death occurred.

In terms of efficacy, both dosing regimens demonstrated preliminary efficacy in the study population. The confirmed objective response rate was 35.9% in the 2.4 mg/kg once every two weeks group and 28.6% in the 3.6 mg/kg once every three weeks group. The median duration of response for patients achieving confirmed response was 8.2 months and 10.3 months, respectively; the 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 SYS6002 2.4 mg/kg once every two weeks regimen for immunotherapy-treated advanced cervical cancer has entered a Phase III clinical trial (NCT07230626).