NCT06350006 SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
| NCT ID | NCT06350006 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. |
| Condition | CLDN18.2-positive Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 924 participants |
| Start Date | 2024-05-29 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 924 participants in total. It began in 2024-05-29 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study consists of two research phases: Phase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study. Phase III: A randomized, Open-Label, multicenter clinical study of SHR-A1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors.
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. 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 subject has other factors that could have affected the study results or led to the forced termination of the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06350006 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying CLDN18.2-positive Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06350006 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06350006 currently recruiting?
Yes, NCT06350006 is actively recruiting participants. Contact the research team at qi.shi.qs16@hengrui.com for enrollment information.
Where is the NCT06350006 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06350006 clinical trial?
NCT06350006 is sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.. The trial plans to enroll 924 participants.