SHR-1826 Advanced Drug Monograph

SHR-1826

English Name: SHR-1826

SHR-1826 is an antibody-drug conjugate (ADC) targeting c-Met. It is currently under development by Suzhou Suncadia Biopharmaceuticals.

Mechanism of Action: The mechanism of action is currently undefined but classified as a c-Met inhibitor. ADCs typically work by combining the specificity of an antibody for a tumor-associated antigen (in this case, c-Met) with a cytotoxic drug. The antibody binds to the cancer cell, and the ADC is internalized, releasing the cytotoxic drug inside the cell to kill it.

Clinical Trials: SHR-1826 is being evaluated in several Phase 1 and Phase 2 clinical trials for various advanced solid tumors, including:

• NCT06703177: A Phase 1/2 study evaluating SHR-1826 in combination with other antitumor therapies in subjects with advanced solid tumors. This study is currently recruiting.
• NCT06094556: An open-label Phase 1 study of SHR-1826 monotherapy in patients with advanced solid tumors. This study is currently recruiting.
• NCT06844474: A Phase 2 study evaluating the safety, tolerability, and efficacy of SHR-1826 in combination with other anti-cancer treatments in patients with non-small cell lung cancer (NSCLC). This study is currently recruiting.
• NCT06935175: A Phase 2 study of SHR-1826 monotherapy or in combination with immunotherapy in patients with advanced hepatocellular carcinoma. This study is not yet recruiting.
• NCT06915142: A Phase 2 study on the safety, tolerability, and efficacy of HRS-7058 (another agent) in combination with antitumor drugs, including SHR-1826, in subjects with solid tumors. This study is not yet recruiting.

Side Effects: Specific side effects of SHR-1826 are still under investigation in ongoing clinical trials. Exclusion criteria for these trials provide some insight into potential risks and contraindications, including:

• History or clinical symptoms of central nervous system metastasis or meningeal metastasis.
• Previous or co-existing malignancies.
• Uncontrollable tumor-related pain.
• Prior treatment with antibody-drug conjugates with a topoisomerase I inhibitor toxin or EGFR/c-Met double antibody.
• Recent major surgery.
• Unresolved severe toxicities from previous anticancer therapy.
• History of interstitial pneumonia/non-infectious pneumonia.
• Uncontrolled pleural effusion, pericardial effusion, or ascites.
• Intestinal obstruction.
• Poorly controlled or severe cardiovascular disease.
• Active hepatitis B or C.
• History of immunodeficiency.
• Severe infection within 30 days prior to the first dose.

Note: This report is based on currently available information from clinical trial registries and may not be exhaustive. More detailed information on the mechanism of action, efficacy, and safety profile of SHR-1826 will emerge as clinical trials progress.