The Global Annual Meeting of the International Gynecologic Cancer Society (IGCS) was held in Montreal, Canada, from October 1 to 3, 2026. At the meeting, Phase I study results of monotherapy with CSPC Innovation’s SYS6002 for advanced cervical cancer were presented in the form of a Rapid Oral Presentation on October 2.

SYS6002 is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4. Leveraging an enzymatic site-specific antibody conjugation technology, the agent delivers monomethyl auristatin E (MMAE), a potent mitotic inhibitor, specifically to Nectin-4-expressing cancer cells. Its stable linker design not only facilitates delivery of high concentrations of MMAE into tumors but also reduces toxicity by lowering systemic exposure to the toxin.

This 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, CSPC Group presented trial results of SYS6002 monotherapy (2.4 mg/kg once every two weeks and 3.6 mg/kg once every three weeks) in previously treated advanced cervical cancer.

As of the data cutoff date of May 8, 2026, 39 patients received SYS6002 at 2.4 mg/kg once every two weeks, and 43 patients received 3.6 mg/kg once every three weeks, with a median follow-up of 16.1 months.

The safety profile was generally manageable across both dose cohorts. Most treatment-related adverse events (TRAEs) were Grade 1–2. Ocular adverse events were the most common; however, no Grade ≥3 events were observed, and no patients discontinued treatment due to these events. The incidence of interstitial lung disease and non-infectious pneumonitis was low (2.4%). The incidence and severity of treatment-related rash were low (any grade: 20.7%; Grade ≥3: 1.2%), with no cases of Stevens-Johnson syndrome or toxic epidermal necrolysis reported. Peripheral neuropathy was also uncommon and mild (12.2%; all Grade 1–2). No treatment-related adverse events leading to death occurred.

Promising Preliminary EfficacyBoth regimens demonstrated preliminary efficacy in the study population. The confirmed objective response rates (cORR) were 35.9% in the 2.4 mg/kg once-every-two-weeks cohort and 28.6% in the 3.6 mg/kg once-every-three-weeks cohort. Among responders with confirmed response, the median duration of response (mDOR) was 8.2 months and 10.3 months, respectively. The median progression-free survival (mPFS) was 4.1 months and 4.3 months, and the median overall survival (mOS) was 15.1 months and 11.5 months.

The Phase III trial (NCT07230626) of SYS6002 at 2.4 mg/kg once every two weeks in immunotherapy-pretreated patients with advanced cervical cancer is ongoing.