Testing GKL-006 injection in people with advanced pancreatic cancer

Trial details

Who runs it

Beijing Gene Key Life Technology Co., Ltd

Trial code

NCT07777211

Record updated

4 November 2026

Original description

This is a Phase I/IIa, multicenter study designed to evaluate the safety, tolerability, and efficacy of GKL-006 injection in patients with ductal adenocarcinoma of pancreas.Read full original descriptionShow less

A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of GKL-006 Injection in Patients With Advanced Pancreatic Cancer

This is a Phase I/IIa, multicenter study designed to evaluate the safety, tolerability, and efficacy of GKL-006 injection in patients with ductal adenocarcinoma of pancreas.

Inclusion: 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.

Exclusion: 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; 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; 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.

ClinicalTrials.gov NCT07777211