SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor

Launched by SHANGHAI HENGRUI PHARMACEUTICAL CO., LTD. · Apr 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called SHR-A1904 for patients with advanced solid tumors that test positive for a specific protein called CLDN18.2. The study has two main phases. The first phase looks at how safe and effective SHR-A1904 is, while also figuring out the best dose to use. In the second phase, researchers will compare this new treatment combined with standard chemotherapy and immunotherapy against the standard treatments alone to see which approach works better.

To participate in this trial, eligible patients need to be between 18 and 75 years old, have advanced tumors that cannot be surgically removed, and have a confirmed positive result for the CLDN18.2 protein in their tumor tissue. Participants should expect regular check-ups and assessments to monitor their health and response to the treatment. It’s important to note that certain health conditions or previous treatments may prevent some individuals from joining the study. If you or a loved one are interested, discussing this with a healthcare provider can help determine eligibility and whether this trial is a good option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 to 75 years old (including boundary values);
• • 2. Volunteer to participate in this clinical study and sign informed consent;
• • 3. ECOG score 0-1;
• • 4. Expected survival ≥3 months;
• • 5. Pathologically confirmed locally advanced unresectable or metastatic solid tumors;
• • 6. positive CLDN18.2 expression in tumor tissue;
• • 7. There is at least one measurable lesion that meets the RECIST 1.1 criteria;
• • 8. Adequate bone marrow and organ function.
• Exclusion Criteria:
• • 1. Plan to receive any other antitumor therapy during this trial; Received other investigational drugs or treatments that are not on the market within 4 weeks prior to the first administration; Anti-tumor therapy, such as chemotherapy, radiotherapy, biotherapy, targeted therapy or immunotherapy, was received within 4 weeks before the first administration of the study drug. Palliative radiotherapy or local therapy within 2 weeks before the first administration of the study drug; Had major surgery other than diagnosis or biopsy within the 4 weeks prior to the first administration or randomization and required elective surgery during the trial.
• • 2. Stage III: HER2 expression in tumor tissue is positive.
• • 3. The adverse reactions of previous anti-tumor therapy has not recovered to NCI-CTCAE v5.0 grade≤ 1.
• • 4. Has ≥ grade 2 peripheral sensory neuropathy.
• • 5. Has an allergic reaction to any of the components treated in this study, or are allergic to humanized monoclonal antibody products.
• • 6. Has a history or current history of meningeal metastasis; or active brain metastases.
• • 7. Presence of dysphagia or other factors affecting the use of oral medications.
• • 8. Additional malignancy within the five years prior to the first administration or randomization.
• • 9. Has an active autoimmune disease or a history of autoimmune disease.
• • 10. Received systemic use of corticosteroids or other immunosuppressants for immunosuppressive effects within 14 days prior to the first administration or randomization.
• • 11. Has a history of clinically significant lung disease.
• • 12. Has serosal effusion ≥ grade 3 (based on NCI CTCAE5.0 criteria).
• • 13. There was an active infection requiring systemic treatment within 2 weeks prior to the first administration or randomization.
• • 14. A history of immunodeficiency, including a positive HIV test; Presence of active hepatitis B or hepatitis C.
• • 15. People who have previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.
• • 16. Has severe cardiovascular and cerebrovascular diseases.
• • 17. Gastrointestinal perforation and/or gastrointestinal fistula within the last 6 months prior to the first administration or randomization; Active gastrointestinal bleeding occurred 3 months before the first administration or randomization.
• • 18. In the investigator's judgment, the subjects has other factors that could have affected the study results or led to the forced termination of the study.