Evaluating SHR-4602 for advanced malignant solid tumors

A Phase I Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4602 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects

This study is testing a new treatment called SHR-4602 to see if it can help people with advanced solid tumors that have HER2 mutations or expressions, especially those who haven’t had success with standard treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 133 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05819684 on ClinicalTrials.gov

What this trial studies

This open-label, three-part study aims to assess the safety, tolerability, pharmacokinetics, and immunogenicity of SHR-4602 in patients with advanced malignant solid tumors that express or have mutations in HER2. The study will also evaluate the preliminary anti-tumor efficacy of the treatment. Participants must have tumors that are either refractory to standard treatments or for which no standard treatment is available. The study will include patients with measurable lesions and adequate organ function.

Who should consider this trial

Good fit: Ideal candidates are patients with advanced or metastatic solid tumors expressing HER2 who have not responded to standard therapies.

Not a fit: Patients with known CNS metastasis, severe lung diseases, or active autoimmune disorders 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 that are difficult to treat.

How similar studies have performed: While this approach is focused on a specific treatment, similar studies targeting HER2 in advanced solid tumors have shown promise in the past.

Eligibility 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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Xin Shi

Conditions: Advanced Solid Tumor