From May 29 to June 2, 2026, the annual meeting of the American Society of Clinical Oncology (ASCO) will be held in Chicago, USA. At this year’s ASCO conference, CSPC Innovation will present five latest clinical trial progressions of four pipeline products.
B7-H3 ADC SYS6043
Phase I/II Clinical Study of SYS6043 Monotherapy in Advanced Solid Tumors: Oral Presentation (Abstract No.: 3002)This is a multicenter, open-label Phase I/II study jointly led by Professor Zhang Li from Sun Yat-sen University Cancer Center and Professor Wu Lingying from National Cancer Center/National Clinical Research Center for Cancer, Chinese Academy of Medical Sciences. The study aims to evaluate the safety, tolerability, pharmacokinetic profiles and preliminary efficacy of SYS6043 in previously treated patients with advanced solid tumors.
About SYS6043
SYS6043 is a B7-H3-targeted antibody-drug conjugate (ADC) independently developed by CSPC Innovation. It adopts a topoisomerase I inhibitor as the payload with a drug-to-antibody ratio (DAR) of approximately 6 mg. Engineered with Fcγ receptor effector silencing design and cleavable linkers, SYS6043 is designed to enhance anti-tumor activity and reduce off-target toxicity. Currently, in the ongoing clinical study for a variety of advanced solid tumors in China, preliminary efficacy signals have been observed in multiple tumor types, including lung cancer, nasopharyngeal carcinoma, breast cancer and gynecological tumors.
Nectin-4 ADC SYS6002
Phase I Clinical Study of SYS6002 Monotherapy in Advanced Solid Tumors: Poster (Abstract No.: 4579)This is a first-in-human, multicenter, Phase I clinical trial led by Professor Ye Dingwei and Professor Zhang Jian from Fudan University Shanghai Cancer Center. It is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYS6002 in patients with advanced solid tumors.
About SYS6002
SYS6002 is a new-generation antibody-drug conjugate (ADC) targeting Nectin-4. By adopting enzyme-catalyzed site-specific antibody conjugation technology, the drug selectively delivers the potent mitotic inhibitor MMAE to Nectin-4-expressing cancer cells. Its stable linker design not only facilitates the delivery of high concentrations of MMAE to tumor tissues, but also reduces toxicity by minimizing systemic exposure of the toxin. In this clinical study, single-agent SYS6002 demonstrated a favorable safety profile in patients with solid tumors and exhibited preliminary efficacy in patients with urothelial carcinoma.
EGFR ADC SYS6010
Phase II Study of SYS6010 in the Treatment of Advanced Solid Tumors: Poster (Abstract No.: 4047)This is a Phase II study of SYS6010 monotherapy for advanced solid tumors led by Professor Lin Rongbo from Fujian Cancer Hospital, presenting data from the esophageal cancer cohort.
About SYS6010
SYS6010 is an antibody-drug conjugate (ADC) developed by CSPC Jushi Biopharmaceutical Co., Ltd., a holding subsidiary of CSPC Innovation. Its antibody moiety is SYS6010 mAb, a recombinant humanized antibody targeting EGFR, which can specifically bind to the surface of EGFR-expressing cells and undergo intracellular internalization. The linker-drug moiety consists of a tetrapeptide linker GGFG conjugated with a topoisomerase I inhibitor.China has a high incidence of esophageal squamous cell carcinoma (ESCC), ranking seventh among all malignancies, with approximately 224,000 new cases and 188,000 deaths annually, accounting for nearly half of the global burden. In recent years, platinum-based chemotherapy combined with immunotherapy has become the standard treatment for advanced ESCC. However, treatment options remain extremely limited for patients with disease progression after platinum-based chemotherapy and immunotherapy, representing a major unmet clinical need.Study results demonstrated that SYS6010 monotherapy (3.6 mg/kg, Q2W) yielded favorable efficacy and safety in patients with ESCC who failed prior standard therapies, with particularly improved outcomes in TOPOi-naïve patients.
EGFR ADC SYS6010 Combined with ATM Inhibitor SYH2051 for Advanced Solid Tumors: Phase Ib/II Study: Poster (Abstract No.: 4044)
This Phase Ib/II study evaluating SYS6010 in combination with SYH2051 for advanced solid tumors is led by Professor Lin Rongbo from Fujian Cancer Hospital, with results from the gastric cancer cohort to be presented.
About SYS6010 and SYH2051
SYS6010, a Class 1 innovative anti-tumor ADC targeting EGFR, binds to EGFR receptors on tumor cell surfaces and enters cells via endocytosis. It is degraded by proteases in lysosomes to release the payload JS-1, a novel topoisomerase I inhibitor. JS-1 forms stable complexes with DNA to induce DNA damage and trigger tumor cell apoptosis, while exerting a bystander effect to non-specifically eliminate adjacent tumor cells.SYH2051 is a proprietary compound developed by CSPC Pharmaceutical Group. It selectively targets and inhibits ATM protein kinase, as well as the phosphorylation of its downstream signaling proteins CHK2 and KAP1. This mechanism delays the repair of DNA double-strand breaks, leading to persistent DNA damage and ATM-mediated cell cycle arrest, thereby suppressing tumor cell proliferation.Preclinical pharmacodynamic studies have verified the synergistic anti-tumor efficacy of SYS6010 combined with SYH2051 in non-small cell lung cancer (NSCLC) animal models. In this clinical trial, the combination regimen exhibited preliminary anti-tumor activity in advanced gastrointestinal tumors with EGFR expression, especially in gastric cancer patients who had received two lines of prior treatment.
Phase II Study of EGFR ADC SYS6010 Plus PD‑1 Inhibitor Enlonstobart (SG001) in Recurrent or Metastatic Esophageal Cancer: Online Publication (e16052)
This is an open-label, multicenter Phase I/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetic profiles and preliminary efficacy of SYS6010 in combination with Enlonstobart Injection with or without chemotherapy in patients with EGFR and ALK wild-type advanced NSCLC and other advanced solid tumors. The esophageal cancer cohort results, led by Academician Xu Ruihua from Sun Yat-sen University Cancer Center, will be released at this conference.
SYS6010, a Class 1 novel anti-tumor drug, is a new-generation antibody-drug conjugate (ADC) composed of a humanized IgG1 monoclonal antibody targeting EGFR conjugated with a topoisomerase I inhibitor. Enlonstobart is a fully human anti‑PD‑1 IgG4 monoclonal antibody.For recurrent or metastatic esophageal cancer and certain advanced solid tumors, PD‑1-based chemoimmunotherapy has become the standard treatment regimen; nevertheless, substantial unmet clinical needs still remain. Mechanistically, certain EGFR-targeted ADCs can produce synergistic anti-tumor effects when combined with PD‑1 immunotherapy to further strengthen anti-tumor activity. In this clinical study, the combination of SYS6010 and Enlonstobart initially demonstrated a favorable safety profile and promising efficacy in patients with recurrent or metastatic esophageal cancer.