SHR-4506 injection for adults with malignant tumors

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4506 Injection in Patients With Malignant Tumors

This trial will test whether SHR-4506 injection is safe and tolerable in adults with malignant tumors who have exhausted or cannot use standard treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT07068932 on ClinicalTrials.gov

What this trial studies

SHR-4506 injection is being tested in a Phase 1 dose-escalation study to find the maximum tolerated or maximum administered dose and to characterize safety and tolerability. Eligible adults have histologically or cytologically confirmed malignant tumors, ECOG performance status 0–1, adequate organ function, and have failed or are intolerant of standard therapies. The protocol includes a dose-expansion phase for patients with measurable disease and excludes those with CNS tumor involvement, active autoimmune disease, immunodeficiency, uncontrolled tumor-related pain, or prior exposure to the same drug class. Study visits and treatment are conducted at Ruijin Hospital and Renji Hospital, both affiliated with Shanghai Jiao Tong University School of Medicine in Shanghai.

Who should consider this trial

Good fit: Adults (≥18 years) with confirmed malignant tumors, ECOG 0–1, adequate organ function, expected survival of at least 12 weeks, and who have failed or cannot tolerate standard treatments are the intended participants.

Not a fit: Patients with confirmed or suspected CNS tumor involvement, active autoimmune disease, immunodeficiency (including HIV), uncontrolled tumor-related pain, or prior treatment with the same class of drug are excluded and unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, SHR-4506 could provide a new treatment option for patients with malignant tumors who lack effective standard therapies, potentially controlling disease with an acceptable safety profile.

How similar studies have performed: This Phase 1 dose-escalation approach is standard for novel oncology drugs; some related early-phase programs have shown preliminary signals but the approach remains unproven in larger trials.

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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
• Renji Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Jie Shen

Conditions: Malignant Tumors of Adults