Treatment for advanced solid tumors targeting mesothelin
An Exploratory Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SY001 Injection Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
This study is testing a new treatment called SY001 for people with advanced ovarian and pancreatic cancers to see if it is safe and effective after other treatments have not worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Cell Origin Biotech (Hangzhou) Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Hangzhou, Zhejiang and 1 other locations) |
| Trial ID | NCT06562647 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of SY001, a treatment targeting mesothelin in patients with advanced solid tumors, specifically ovarian and pancreatic cancers. It employs a single-arm, dose-increasing design using the '3+3' approach for dose escalation. The study aims to assess pharmacokinetics, cytokine levels, and the correlation between SY001's efficacy and patient outcomes. Participants must have measurable tumor lesions and have previously failed at least one line of treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced ovarian or pancreatic cancer who have failed prior treatments and have tumors that test positive for mesothelin.
Not a fit: Patients who are pregnant, lactating, or have uncontrolled active infections 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 overexpress mesothelin.
How similar studies have performed: While this approach is novel, similar studies targeting mesothelin have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with pathologically diagnosed advanced ovarian cancer/pancreatic cancer who have failed at least 1 prior lines treatment, and tumor tissue samples were positive for mesothlin IHC staining; 2. According to the RECIST 1.1, there is measurable tumor lesions (non-lymph node lesion 10mm in length or lymph node lesion 15mm in diameter measured by CT or MRI, with scan layer thickness 5mm); 3. Eastern Cooperative Oncology Group (ECOG) score of 2 and satisfactory major organ functions; 4. Estimated life expectancy \>3 months; 5. Female patients of childbearing age must undergo a serum pregnancy test at screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study treatment. Exclusion Criteria: 1. Pregnant or lactating women; 2. Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection; 3. Patients who have a history of other mesothelin-targeting therapy; 4. Patients who have a history of autoimmune disease; 5. The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.
Where this trial is running
Hangzhou, Zhejiang and 1 other locations
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- Linyi Cancer Hospital — Linyi, China (Not_yet_recruiting)
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.