Evaluating SHR-4375 for patients with solid tumors
An Open-label, Single-arm, Multicenter Phase I/II Clinical Study of SHR-4375 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy
This study is testing a new treatment called SHR-4375 to see if it can help people with advanced solid tumors who haven't had success with other therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06764628 on ClinicalTrials.gov |
What this trial studies
This open-label, three-part study aims to assess the safety and efficacy of SHR-4375 in individuals diagnosed with solid tumors. Participants will receive SHR-4375 injections and will be monitored for their response to the treatment. The study includes patients who have advanced solid tumors and have either failed standard therapies or are intolerant to them. The research will follow strict eligibility criteria to ensure the safety and appropriateness of the participants.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced solid tumors who have not responded to or cannot tolerate standard treatments.
Not a fit: Patients with untreated central nervous system metastases or active autoimmune diseases 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 who have limited alternatives.
How similar studies have performed: While this approach is being explored, similar studies have shown promise in targeting solid tumors with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The subjects voluntarily joined the study and signed the ICF. 2. Measurable disease, as defined by RECIST v1.1. 3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1. 4. Life expectancy ≥ 12 weeks. 5. Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy. Exclusion Criteria: 1. Symptomatic, untreated or active central nervous system metastases. 2. With any active autoimmune disease or history of autoimmune disease. 3. Patients with active hepatitis B or hepatitis C. 4. Severe infections prior to initiation of study treatment.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yuanchao Wang
- Email: yuanchao.wang@hengrui.com
- Phone: 0518-82342973
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.