A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2026-05-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Criteria

Inclusion Criteria:

1. Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;

2. At least one measurable lesion based on RECIST v1.1 criteria;

3. ECOG PS score: 0-1 points;

4. Expected survival period ≥ 3 months;

5. Adequate organ function;

6. Must take one medically approved contraceptive measure;

7. Patients voluntarily joined the study and signed informed consent.

Exclusion Criteria:

1. Patients with known CNS metastasis or hepatic encephalopathy;

2. Suffering from peripheral neuropathy;

3. History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period;

4. Patients with any active, known or suspected autoimmune disorder;

5. With known severe allergic reactions to any other monoclonal antibodies;

6. Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose;

7. Patients with other malignancies currently or within the past 5 years;

8. Uncontrolled cardiac diseases or symptoms;

9. With known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs);

10. Patients with other potential factors that may affect the study results.