Can a new injection boost chemotherapy against pancreatic cancer?

NCT ID NCT07777211

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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