SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SY001.
- Who it may be relevant to
- Registry conditions: Treatment Related Cancer, Ovarian Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
Single-arm, dose-increasing setting study of CAR macrophages in Mesothelin overexpressing solid tumors.
Detailed description
This study was a single-arm, single-center, dose-increasing design, using the "3+3" approach for dose escalation, to evaluate the safety, tolerability and initial effectiveness of SY001, and to evaluate the pharmacokinetic characteristics, cytokines and the correlation between the efficacy of SY001.
Interventions
- Drug SY001
PBMC-derived anti-mesothelin Cheimeric Antigen Receptor macrophages
Primary outcome measures
- Identification of Maximum Tolerated Dose (MTD) [Time frame: up to 28 days after SY001 infusion.]
Secondary outcome measures (4)
- Objective response rate (ORR) [Time frame: 3 months]
- Time to Peak (Tmax) [Time frame: 1 month]
- Area Under the Plasma Concentration Versus Time Curve (AUC) [Time frame: 1 month]
- Maximum Plasma Concentration of cytokines (Cmax) [Time frame: 1 month]
Eligibility criteria
Inclusion criteria
- 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;
- 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);
- Eastern Cooperative Oncology Group (ECOG) score of 2 and satisfactory major organ functions;
- Estimated life expectancy >3 months;
- 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
- Pregnant or lactating women;
- Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;
- Patients who have a history of other mesothelin-targeting therapy;
- Patients who have a history of autoimmune disease;
- The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
- Linyi Cancer Hospital — Linyi
Identifiers
NCT: NCT06562647 · KY2303