Evaluating SHR-3792 Injection for Advanced Solid Tumors

A Phase Ⅰ, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-3792 in Patients With Advanced Solid Tumors

This study is testing a new injection called SHR-3792 to see if it can safely help people with advanced solid tumors feel better and how much of it they should take.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06907628 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of SHR-3792 injection as a monotherapy for patients suffering from advanced solid tumors. The study will also explore appropriate dosing for this treatment. Participants will be monitored for their response to the injection and any potential side effects throughout the trial. The trial is designed for patients with unresectable recurrent or metastatic solid tumors who meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable recurrent or metastatic solid tumors who have a life expectancy of at least three months.

Not a fit: Patients with active central nervous system metastases or those with other serious 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.

How similar studies have performed: While this approach is being explored in this trial, similar studies have shown promise in evaluating new treatments for advanced solid tumors.

Eligibility criteria

Inclusion Criteria:

1. Subjects with ability to understand and voluntarily agree to participate by giving written informed consent form for the study.
2. Patients with unresectable recurrent or metastatic solid tumors.
3. There is at least one lesion that could be measured.
4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
5. Adequate organ functions as defined.
6. Life expectancy ≥ 3 months.

Exclusion Criteria:

1. Patients with known active central nervous system (CNS) metastases.
2. Subjects with other malignancy in five years before the first dose.
3. Patients with tumor-related pain that cannot be controlled as determined.
4. Patients with serious cardiovascular and cerebrovascular diseases.
5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.
6. Patients with severe infections.
7. History of immunodeficiency.
8. History of autoimmune diseases.
9. Active infection.
10. Pregnant or nursing women.
11. Known history of serious allergic reactions to the investigational product or its main ingredients.

Where this trial is running

Jinan, Shandong

• Shandong First Medical University Affiliated Cancer Hospital — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Fangfang Peng

Conditions: Advanced Solid Tumors