A Study of GKL-006 Injection in Patients With Advanced Pancreatic Cancer

Korábbi kezelés

• Active, known, or suspected autoimmune disease, or systemic corticosteroid/immunosuppressive therapy within 4 weeks before screening.
• Major surgery or severe trauma within 6 months before screening, or planned major surgery during the study.
• Clinically significant proteinuria within 7 days before enrolment.
• Toxicity from prior anticancer therapy not recovered to protocol-specified levels.
• Clinically significant bleeding within 4 weeks, GI bleeding within 6 months, major-vessel invasion with a high bleeding risk, a known bleeding/thrombotic disorder, or arterial/venous thromboembolism within 6 months before enrolment/randomisation.
• Active systemic infection requiring treatment within 2 weeks, or unexplained fever or clinically significant leukocytosis within 7 days before enrolment.
• Prior genetically modified cell therapy, or non-genetically modified cell therapy within 6 months before screening.
• Receipt of an attenuated vaccine or participation in another drug/device clinical study within 4 weeks before screening.

Más betegség

• Known hypersensitivity to any component of the study treatments.
• Other unresolved malignancy within 5 years or concurrently, except specified adequately treated malignancies.
• History or presence of clinically significant interstitial lung disease or active infection.
• Poorly controlled or clinically significant cardiovascular disease, including inadequately controlled hypertension within 7 days, unstable angina within 6 months, or acute myocardial infarction within 1 year before enrolment.
• Congenital or acquired immunodeficiency, active syphilis or another serious active infection, or HBV/HCV infection with detectable viral load at screening.

Egyéb

• Known brain or meningeal metastases, except stable brain metastases.
• Symptomatic ascites or pleural effusion.
• History or presence of tumour-related GI obstruction requiring treatment.
• Any contraindication to IL-2.
• Pregnancy or breastfeeding.

• Aged 18-75 years, inclusive, with no sex restriction.
• Histologically or cytologically confirmed unresectable locally advanced or metastatic PDAC.
• No prior systemic therapy for unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma. Prior neoadjuvant or adjuvant therapy will not be considered prior systemic therapy for advanced disease.
• For patients with postoperative recurrence or metastasis who previously received neoadjuvant or adjuvant therapy, disease progression or recurrence must have occurred at least 6 months after completion of prior therapy.
• At least one measurable lesion during screening, as defined by RECIST version 1.1.
• Able to understand and voluntarily sign the ICF, communicate adequately with the investigator, comply with study procedures and follow-up, and meet all study requirements.
• ECOG PS 0 or 1 and a life expectancy of at least 12 weeks.
• Adequate haematological and organ function, as demonstrated by protocol-specified laboratory values obtained within 14 days before enrolment or randomisation.
• No traditional Chinese medicine with an antitumour indication within 7 days before enrolment or randomisation.
• Participants of reproductive potential must use medically accepted contraception during study treatment and for 6 months after the end of treatment.