Abstract #3016: First-in-human dose escalation and expansion study of SYSA1801, an antibody-drug conjugate targeting Claudin 18.2 in patients with resistant/refractory solid tumors Yakun Wang1, Jifang Gong1, Rongbo Lin2, Shen Zhao2, Jufeng Wang3, Qianli Wang3,Yan-qiao Zhang4, Dan Su4, Jingdong Zhang5, Qian Dong5, Ling Lin6, Wen Tian6, Ying Chen7, Yang Yang7, Xueyuan Zhang7, Xuechao Wan7, Jinfeng Gao7, Na An7, Valerie Malyvanh Jansen8, Lin Shen1; 1Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China; 2Fujian Cancer Hospital, Fuzhou, China; 3The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China; 4Harbin Medical University Cancer Hospital, Harbin, China; 5Liaoning Cancer Hospital & Institute, Cancer Hospital of China Medical University, Shenyang, China; 6The Third People’s Hospital of Hainan Province, Haikou, China; 7CSPC Pharmaceutical Group Limited, China; 8Elevation Oncology, Inc., New York, NY. Contact email: wykun1991@126.com Background • SYSA1801 is a monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC) targeting claudin 18.2 (CLDN18.2), a tight junction protein broadly expressed in gastric, pancreatic, and other solid tumors. • CLDN18.2 has a highly selective cell surface expression profile that is limited to normal gastric mucosa, making it a promising ADC therapeutic target. • SYSA1801 has shown significant in vitro and in vivo anti-tumor activity in multiple cell lines and xenografts expressing CLDN18.2. Methods • In this open-label, multi-center, phase I study, patients with histologically confirmed resistant/refractory solid tumors that express CLDN18.2 who progressed on or were intolerant to standard treatment, or had no standard treatment were recruited. Outcomes • The primary endpoint was safety, adverse events were graded according to CTCAE 5.0. • The secondary endpoints were pharmacokinetics profiles and efficacy as per RECIST 1.1. Table 1. Demographics and baseline characteristics of enrolled patients Efficacy • 21 patients were evaluable for response, while 12 patients did not have their first tumor assessment due to adverse events (n=4), not reached assessment date (n=4), unknown death (n=2; not related to study drug) and withdrawal (n=2). • Efficacy outcomes were summarized in Table 3 and Figure 1. Results • Data cut-off date: November 5, 2022. • 33 eligible patients were enrolled to receive up to SYSA1801 3.0 mg/kg. • The demographics and baseline characteristics were summarized in Table 1. Conclusion • SYSA1801 exhibited promising early signs of efficacy with a well-tolerated safety profiles in patients with CLDN18.2-expressing resistant/refractory solid tumors, especially gastric cancer. • Dose expansion study is ongoing with cohort expansion study to start when the optimized dose is determined in China; studies outside of Greater China including in the United States are being planned by Elevation Oncology. Table 2. Treatment-related adverse events (occurring in >20% of patients) Acknowledgment • The authors would like to thank all patients who participated in this study. This trial is supported by CSPC Zhongqi Pharmaceutical Technology Co., Ltd. Effi Safety • Two DLTs (grade-3 nausea and vomiting) occurred at the 3.0 mg/kg dose. • Treatment-related adverse events (TRAEs) of any grade occurred in 25 patients LQZKLFK ZHUH•JUDGH. No treatment related death was reported. • The most common TRAEs were summarized in Table 2. Table 3. Tumor response by dose levels Before treatment 6 weeks after treatment • Among 17 evaluable patients with gastric cancer, ORR and DCR were 47.1% (95% CI: 23.0-72.2%, 8 PRs) and 64.7% (95% CI: 38.3-85.8%, 3 SDs). • One patient with gastric cancer receiving SYSA1801 at 1.0 mg/kg IV Q3W tolerated treatment for 44 weeks with durable confirmed partial response ongoing at the time of analysis. • Another patient with gastric cancer who failed previous anti-CLDN18.2 treatment achieved partial response on SYSA1801 2.0 mg/kg IV Q3W Figure 1. Waterfall plot of best percentage change of target lesions from baseline- all efficacy evaluable patients Figure 2. Activity of SYSA1801 in gastric cancer • 64y, female • CLDN 18.2 IHC 3+35%漕 2+15%漕 1+10% • Previously treated with 3 lines of therapy • Received SYSA1801 at 2.0 mg/kg Safet y p |
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8-K Filing
Elevation Oncology (ELEV) 8-KClinical Data to be Presented by Partner CSPC Pharmaceutical Group Limited at Elevation Oncology on track to initiate Phase 1 clinical trial in the US in the second half of 2023
Filed: 5 Jun 23, 7:00am
Exhibit 99.2