Evaluating SHR-4375 for patients with solid tumors
Official title: 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
Run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · NCT06764628 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 208 (estimated) |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | January 9, 2025 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | January 22, 2025 |
| Trial ID | NCT06764628 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with advanced solid tumors who have not responded to or cannot tolerate standard treatments.
✕Probably not a fit
Patients with untreated central nervous system metastases or active autoimmune diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is being explored, similar studies have shown promise in targeting solid tumors with novel therapies.
Who can join: the full rules
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 it's running
-
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Yuanchao Wang
- Email: yuanchao.wang@hengrui.com
- Phone: 0518-82342973
Similar studies
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ONO-7429 in advanced or recurrent solid tumors
This small early-phase study tests whether ONO-7429 is tolerable and safe in adults with unresectable advanced or recurrent solid tumors who have tried other treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.