From January 25th to 27th local time, the 2024 American Society of Clinical Oncology Urogenital Oncology Branch (ASCO-GU) annual meeting was grandly held in San Francisco. ASCO GU is an academic event in the field of urogenital tumors. The conference will showcase the most innovative scientific progress in this field and discuss the future treatment directions of urogenital tumors.

The first human study of SYS6002, a collaboration between CSPC and Fudan University Cancer Hospital’s Professor Ye Dingwei’s team and Professor Zhang Jian’s team – “Evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYS6002 in patients with advanced solid tumors "An open, single-arm, multi-center phase I clinical trial" - phased research results were presented at the conference in the form of a poster (number B622).

Research methods

This study is a single-arm, open, multi-center phase I study. Aims to evaluate the safety, tolerability and PK characteristics of SYS6002 in patients with advanced solid tumors; determine the maximum tolerated dose (MTD) and recommended dose (RP2D) of SYS6002 for phase II clinical studies; evaluate SYS6002 in the treatment of urothelial cancer and Preliminary efficacy in other advanced solid tumors with positive Nectin-4 expression.

Research result

As of January 11, 2024, a total of 18 patients have been enrolled in 6 dose groups (0.2, 0.6, 1.2, 1.8, 2.7, 3.6 mg/kg) with tumor types including urothelial cancer, breast cancer, etc., and the subjects The age distribution ranged from 35 to 76 years old, 72% were female, and the median number of lines of treatment before enrollment was 5. Trial data show that no DLT events were observed in the 0.2-3.6mg/kg dose group; most adverse events related to therapeutic drugs were grade 1 to 2, the most common of which were ocular toxicity such as dry eye and anemia; not yet Adverse events such as peripheral neuropathy and rash occurred. The ORR and DCR of SYS6002 at the expected effective dose reached 43% (3/7) and 71% (5/7) respectively; PR occurred in the lower dose group (1.2mg/kg); observed by the deadline The longest response time is 11 cycles (approximately 10 months) and still on treatment.

Analysis conclusion

The above test results show that SYS6002 is well tolerated and shows clear efficacy signals in advanced solid tumors such as urothelial cancer. Dose escalation and expansion phase studies of higher doses of SYS6002 are currently underway.

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