SY001 Targets Mesothelin in a Single-arm, Dose-increasing Setting in Subjects With Advanced Solid Tumors

Launched by CELL ORIGIN BIOTECH (HANGZHOU) CO., LTD. · Aug 18, 2024

Keywords

ClinConnect Summary

The SY001 trial is researching a new treatment for women with advanced ovarian or pancreatic cancer that has not responded to previous therapies. This study focuses on a special type of immune cells called CAR macrophages, which are designed to target a protein called mesothelin that is often found in higher amounts in certain tumors. The trial involves gradually increasing the dose of this treatment to see how well it works and what effects it has on the patients.

To participate, women aged 27 to 93 who have been diagnosed with advanced ovarian or pancreatic cancer and have had at least one previous treatment may be eligible. They need to have tumors that show high levels of mesothelin and measurable tumor lesions as seen on imaging tests. Participants can expect regular check-ups and monitoring throughout the study, and they must agree to use effective birth control if they are of childbearing age. It's important to note that pregnant or breastfeeding women, those with certain active infections, or those with a history of autoimmune diseases cannot participate in this trial.

Gender

FEMALE

Eligibility 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.