Can a new injection boost chemotherapy against pancreatic cancer?
NCT ID NCT07777211
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This early-stage trial is testing an investigational drug called GKL-006, given alongside standard chemotherapy, in people with advanced pancreatic cancer that cannot be removed by surgery. The study aims to see if the combination is safe and tolerable, and whether it shows any promise in shrinking tumors or delaying cancer growth. Participants receive GKL-006 every two weeks along with nab-paclitaxel and gemcitabine, and the trial will closely monitor side effects and treatment response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GKL-006 injection combined with nab-paclitaxel and gemcitabine chemotherapy
- What this could lead to
- If successful, this combination could offer a new treatment option for advanced pancreatic cancer, potentially slowing tumor growth and improving outcomes.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the treatment may not prove effective or safe. Side effects from the combination are possible and not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2025
- Expected to finish
-
Aug 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced pancreatic cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
No. 1 Shuaifuyuan, Wangfujing, Dongcheng District
Beijing, Beijing Municipality, 100010, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Personalized drug matching put to the test in pancreatic cancer
- Can engineered immune cells tackle Hard-to-Treat KRAS cancers?
- Can a targeted antibody slow advanced pancreatic cancer?
- New Antibody-Drug combo takes on Hard-to-Treat pancreatic cancer
- New drug targets Hard-to-Treat pancreatic cancer by hitting a common mutation
- Experimental combo targets Hard-to-Treat pancreatic cancer