Evaluating SHR-7787 Injection for Advanced Solid Tumors
A Phase I/II, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 in Patients With Advanced Solid Tumors
This study is testing a new injection called SHR-7787 to see if it is safe and effective for people with advanced solid tumors that can't be removed by surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 201 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Hengrui Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06605222 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of SHR-7787 injection as a monotherapy for patients suffering from advanced solid tumors. The study will explore appropriate dosing for this treatment in patients with unresectable recurrent or metastatic solid tumors. Participants will be monitored for measurable lesions and overall health status throughout the trial phases.
Who should consider this trial
Good fit: Ideal candidates include patients with unresectable recurrent or metastatic solid tumors who have a good performance status and adequate organ function.
Not a fit: Patients with active central nervous system metastases or those with severe comorbidities 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 specific context, similar studies have shown promise in evaluating new treatments for advanced solid tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study; 2. Patients with unresectable recurrent or metastatic solid tumors; 3. There is at least one lesion 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 who had 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. Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy 10. Active infection; 11. Pregnant or nursing women; 12. Known history of serious allergic reactions to the investigational product or its main ingredients.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ke Ma
- Email: ke.ma@hengrui.com
- Phone: +0518-81220121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.