A Clinical Study of SHR-4506 Injection in Patients With Malignant Tumors

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called SHR-4506, given as an injection, to see if it is safe and well-tolerated in adults with malignant tumors (cancers). The main goal is to find the highest dose patients can safely receive without serious side effects. This is an early phase (Phase 1) study, meaning it focuses mostly on safety rather than how well the drug works.

Adults who have certain types of cancer that have not responded to standard treatments, or who cannot have standard treatments, may be eligible to join. Participants need to be generally healthy enough to take part, with a good performance status (meaning they can carry out daily activities), and should expect to live at least 12 weeks. People with brain involvement of cancer, serious infections, certain heart problems, or other health issues may not be eligible. If you join, you will be closely monitored for side effects, and you will need to agree to use contraception during and for some time after the study. The study is not yet recruiting, but it aims to help find a safe dose of this new treatment for future research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years, any gender.
• • 2. ECOG performance status 0-1.
• • 3. Histologically or cytologically confirmed malignant tumor patients who have failed standard therapy, or are intolerant to standard therapy, or have no standard treatment available.
• • 4. Adequate organ function.
• • 5. Voluntary participation in this clinical trial, with full understanding of study procedures and ability to provide written informed consent.
• • 6. Expected survival ≥12 weeks.
• • 7. Patients in the dose-expansion phase must have measurable lesions.
• • 8. Agreement to use contraception from the time of signing the informed consent to at least 60 days after the last dose of the investigational drug.
• Exclusion Criteria:
• • 1. Prior treatment with the same class of investigational drug.
• • 2. Confirmed or suspected central nervous system (CNS) tumor involvement.
• • 3. Uncontrolled tumor-related pain.
• • 4. Active autoimmune disease, history of immunodeficiency (including primary or secondary, e.g., HIV infection), or autoimmune disorders requiring systemic therapy.
• • 5. Clinically significant cardiovascular disease history.
• • 6. Known hypersensitivity to any component of the investigational drug.
• • 7. Major surgery or significant trauma within 4 weeks prior to the first dose of the investigational drug; diagnostic or superficial surgery within 7 days before the first dose; or planned major surgery during the study period.
• • 8. Adverse events from prior therapy have not recovered to ≤ CTCAE Grade 1.
• • 9. Severe infection within 4 weeks before the first dose, or active infection within 2 weeks.
• • 10. History of cerebrovascular accident within 6 months before the first dose of the investigational drug.
• • 11. Patients with other active malignancies within 2 years prior to the first dose or concurrent malignancies.
• • 12. Patients with any other condition judged by the investigator that makes the patient unsuitable for participation in the study.