Treatment for advanced solid tumors with CLDN18.2 expression

A Phase Ib/III Study of SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor

This study is testing a new treatment called SHR-A1904 for people with advanced solid tumors that have a specific marker, to see if it works better than the usual chemotherapy and immunotherapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 924 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06350006 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of SHR-A1904 in patients with CLDN18.2-positive advanced solid tumors. It consists of a Phase Ib dose escalation and efficacy extension phase, followed by a Phase III randomized study comparing SHR-A1904 combined with chemotherapy and immunotherapy against standard chemotherapy and immunotherapy. The goal is to determine the recommended dose and population for further studies. Participants will be closely monitored for safety and treatment response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced solid tumors that express CLDN18.2 and meet specific health criteria.

Not a fit: Patients who have received other antitumor therapies recently or have certain health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors expressing CLDN18.2.

How similar studies have performed: Other studies targeting CLDN18.2 have shown promise, indicating potential for success with this approach.

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Qi Shi

Conditions CLDN18.2-positive Advanced Solid Tumor