GKL-006 injections with nab-paclitaxel and gemcitabine for advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase I/IIa, multicenter interventional study evaluating the safety, tolerability, and potential efficacy of GKL-006 injections in combination with nab-paclitaxel and gemcitabine for advanced pancreatic cancer. Phase I focuses on safety and tolerability while collecting early signals on pharmacokinetics and pharmacodynamics; Phase II emphasizes efficacy with continued safety assessment. The trial will enroll adults with unresectable locally advanced or metastatic PDAC who have not received prior systemic therapy for advanced disease. Primary endpoints shift from safety in Phase I to efficacy in Phase II, with secondary assessments of PK/PD and continued safety data. Locations are in Beijing, with Beijing Gene Key Life Technology Co., Ltd as the lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18-75 years, inclusive, with no sex restriction.
2. Histologically or cytologically confirmed unresectable locally advanced or metastatic PDAC.
3. 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.
4. 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.
5. At least one measurable lesion during screening, as defined by RECIST version 1.1.
6. 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.
7. ECOG PS 0 or 1 and a life expectancy of at least 12 weeks.
8. Adequate haematological and organ function, as demonstrated by protocol-specified laboratory values obtained within 14 days before enrolment or randomisation.
9. No traditional Chinese medicine with an antitumour indication within 7 days before enrolment or randomisation.
10. Participants of reproductive potential must use medically accepted contraception during study treatment and for 6 months after the end of treatment.

Exclusion Criteria:

1. Known hypersensitivity to any component of the study treatments.
2. Other unresolved malignancy within 5 years or concurrently, except specified adequately treated malignancies.
3. Active, known, or suspected autoimmune disease, or systemic corticosteroid/immunosuppressive therapy within 4 weeks before screening.
4. Major surgery or severe trauma within 6 months before screening, or planned major surgery during the study.
5. Known brain or meningeal metastases, except stable brain metastases.
6. Symptomatic ascites or pleural effusion.
7. History or presence of clinically significant interstitial lung disease or active infection.
8. 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.
9. Clinically significant proteinuria within 7 days before enrolment.
10. Toxicity from prior anticancer therapy not recovered to protocol-specified levels.
11. 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.
12. History or presence of tumour-related GI obstruction requiring treatment.
13. Active systemic infection requiring treatment within 2 weeks, or unexplained fever or clinically significant leukocytosis within 7 days before enrolment.
14. Congenital or acquired immunodeficiency, active syphilis or another serious active infection, or HBV/HCV infection with detectable viral load at screening.
15. Any contraindication to IL-2.
16. Prior genetically modified cell therapy, or non-genetically modified cell therapy within 6 months before screening.
17. Pregnancy or breastfeeding.
18. Receipt of an attenuated vaccine or participation in another drug/device clinical study within 4 weeks before screening.

Where it's running

• No. 1 Shuaifuyuan, Wangfujing, Dongcheng District
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Clinical trial ethics committee subject reception
• Email: tpingzhang@yahoo.com
• Phone: +86-10-69154186

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.