SYH2051 / CSPC Pharma - LARVOL DELTA

SYS6010 combined with SYH2051 in advanced solid tumors: Results from a phase Ib/II trial. (ASCO 2026) - P=N/A | "The combination of SYS6010 and SYH2051 showed acceptable safety and tolerability in patients with advanced solid tumors. Promising antitumor activity was observed in patients with advanced GC, particularly among those receiving the regimen as ≥3rd-line therapy."

Metastases • P1/2 data • Colon Cancer • Colorectal Cancer • Gastric Cancer • Leukopenia • Neutropenia • Oncology • Rectal Cancer • Solid Tumor • Thrombocytopenia

ATM inhibitors in cancer radiotherapy: Mechanisms, clinical development, and future directions. (PubMed, Eur J Med Chem) - "Inhibitors such as KU-55933, KU-60019, and AZD1390 have shown the potential to sensitize cancer cells to radiotherapy by impairing DNA repair, thereby enhancing treatment efficacy...Currently, none have gained approval from the FDA or EMA, but six candidates, AZD1390, AZD0156, ZN-B-2262, SYH2051, WSD0628 and M3541 are in clinical trials, often as adjuncts to radiotherapy or in combination with PARP inhibitors. Their safety and effectiveness, however, are still under investigation. This review synthesizes ATM's dual roles and the therapeutic promise of targeting ATM in cancer radiotherapy."

Journal • Review • Ataxia • Brain Cancer • Immunology • Movement Disorders • Oncology • Primary Immunodeficiency • Solid Tumor • CDKN1A • CHEK1 • CHEK2

A Study of SYS6010 in Combination With SYH2051 in Patients With Advanced Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov) - P=N/A | N=25 | Active, not recruiting | Sponsor: Fujian Cancer Hospital

New trial • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase Ib/II Study on the Safety and Efficacy of SYS6010 and SYS6010 in Combination with SYH2051±Bevacizumab in Patients with Advanced Solid Tumors (ChiCTR) - P1/2 | N=138 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center, Fujian Provincial Cancer Hospital; CSPC Megalith Biopharmaceutical Co., Ltd..

New P1/2 trial • Solid Tumor • EGFR

First-in-human trial of SYS6010 combined with SYH2051 in patients with advanced gastrointestinal tumors. (ASCO 2025) - "SYS6010 combined with SYH2051 was well tolerated and demonstrated preliminary antitumor activity in advanced gastrointestinal tumors, particularly in gastric cancer. Further evaluation is ongoing."

Clinical • Metastases • P1 data • Anemia • Colorectal Cancer • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Infectious Disease • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • KRAS

SYH2051 (SELECTIVE ATM INHIBITOR) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. (HKEXnews) - "The board of directors (the 'Board') of CSPC Pharmaceutical Group Limited (the 'Company', together with its subsidiaries, the 'Group') is pleased to announce that SYH2051 (the 'Product') developed by the Group has been approved by the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the U.S....The indication for this approval is advanced solid tumors."

IND • Solid Tumor

Clinical Trial of SYS6010±SYH2051 Versus Chemotherapy in Advanced Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1/2 | N=410 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

Monotherapy • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor

Small Molecular Inhibitors That Target ATM for Drug Discovery: Current Research and Potential Prospective. (PubMed, J Med Chem) - "Specifically, AZD1390, WSD0628, SYH2051, and ZN-B-2262 are under investigation in clinical studies pertaining to glioblastoma multiforme and advanced solid tumors, respectively. In this Perspective, we encapsulate the structure, biological functions, and disease relevance of ATM. Subsequently, we concentrate on the design concepts and structure-activity relationships (SAR) of ATM inhibitors, delineating potential avenues for the development of more efficacious ATM-targeted inhibitors."

Journal • Review • Ataxia • Brain Cancer • CNS Disorders • CNS Tumor • Glioblastoma • Immunology • Movement Disorders • Oncology • Primary Immunodeficiency • Solid Tumor

A Study of SYH2051 Monotherapy in Advanced Solid Tumors or in Combination With Radiotherapy in Locally Advanced Head and Neck Cancer (clinicaltrials.gov) - P1 | N=73 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Combination therapy • Metastases • Monotherapy • New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor

CSPC (01093.HK) Selective ATM Inhibitor SYH2051 Approved for Clinical Trials [Google translation] (Finet Group) - "CSPC ( 01093.HK ) announced that SYH2051 developed by the group has been approved by the State Drug Administration of China and can conduct clinical trials in China....The clinical indication approved this time is solid tumors."

New trial • Oncology • Solid Tumor