CSPC Pharmaceutical Presents Phase I Data of SYS6002 Monotherapy in Advanced Cervical Cancer as Rapid Oral Report at IGCS 2026

CSPC Pharmaceutical Group Limited (stock code: 01093) announced that Phase I clinical trial data for SYS6002 as monotherapy in advanced cervical cancer were presented as a rapid oral report at the International Gynecologic Cancer Society (IGCS) 2026 Annual Meeting.

The Phase I trial, conducted across multiple centers in China, was designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of SYS6002 in patients with advanced solid tumors. At the meeting, the company presented results from the cohort evaluating SYS6002 monotherapy in previously treated patients with advanced cervical cancer.

As of May 8, 2026, the study enrolled 82 patients across two dose cohorts: 39 patients received 2.4 mg/kg administered once every two weeks (Q2W), and 43 patients received 3.6 mg/kg once every three weeks (Q3W). The median follow-up duration was 16.1 months.

Safety Profile

The safety profile across both dose cohorts was generally manageable, with treatment-related adverse events (TRAEs) predominantly Grade 1-2 in severity. Ocular-related adverse events were the most commonly reported; however, no Grade 3 or higher ocular events occurred, and no patients discontinued treatment due to these events.

The incidence of interstitial lung disease and non-infectious pneumonitis was low at 2.4%. Treatment-related rash was observed in 20.7% of patients at any grade, with only 1.2% experiencing Grade 3 or higher severity. No cases of Stevens-Johnson syndrome or toxic epidermal necrolysis were reported. Peripheral neuropathy occurred in 12.2% of patients, all at Grade 1-2 severity. Notably, no treatment-related deaths were reported.

Efficacy Results

Both dosing regimens demonstrated preliminary efficacy in the study population. The confirmed objective response rate (ORR) was 35.9% in the 2.4 mg/kg Q2W cohort and 28.6% in the 3.6 mg/kg Q3W cohort.

Among patients who achieved confirmed responses, the median duration of response was 8.2 months for the Q2W cohort and 10.3 months for the Q3W cohort. The median progression-free survival (PFS) was 4.1 months and 4.3 months, respectively. The median overall survival (OS) was 15.1 months for the Q2W cohort and 11.5 months for the Q3W cohort.

Next Steps

Based on these promising Phase I results, CSPC has advanced SYS6002 at the 2.4 mg/kg Q2W dosing regimen into a Phase III clinical trial (NCT07230626) for the treatment of immunotherapy-refractory advanced cervical cancer.