A Phase 1/2 interventional study of GKL-006 injection and Nab-paclitaxel and Gemcitabine in Advanced Pancreatic Cancer and Ductal Adenocarcinoma of Pancreas, sponsored by Beijing Gene Key Life Technology Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Beijing Gene Key Life Technology Co., Ltd · Phase 1/2, Interventional, and Treatment
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.
This study will evaluate GKL-006 injection in combination with nab-paclitaxel and gemcitabine in patients with advanced pancreatic cancer. Phase I will primarily assess tolerability and safety, and will also evaluate preliminary efficacy and pharmacokinetic and pharmacodynamic characteristics. Phase II will primarily evaluate efficacy, with further assessment of safety and pharmacokinetic and pharmacodynamic characteristics.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's planned enrollment of 52 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Beijing Gene Key Life Technology Co., Ltd is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low-Dose GKL-006 injection plus AG regimen
Biological: GKL-006 injection · Drug: Nab-paclitaxel and Gemcitabine
High-Dose GKL-006 injection plus AG regimen
Biological: GKL-006 injection · Drug: Nab-paclitaxel and Gemcitabine
Selected dose level of GKL-006 injection from phase I plus AG regimen
Biological: GKL-006 injection · Drug: Nab-paclitaxel and Gemcitabine
AG regimen, Nab-paclitaxel and gemcitabine per protocol
Drug: Nab-paclitaxel and Gemcitabine
GKL-006 injection will be administered at the protocol-defined dose every 2 weeks. Participants in Phase I will receive the assigned low or high dose, and recommended dose in Phase II.
Also known as: GKL-006
Drug pages: Albumin-Bound Paclitaxel · Gemcitabine
Nab-paclitaxel and Gemcitabine are given intravenously as a combination chemotherapy regimen according to the study protocol.
Also known as: nab-P+G, AG
Phase I: Incidence of Dose-Limiting Toxicities
The number and percentage of participants experiencing a dose-limiting toxicity during the protocol-defined DLT evaluation period. Dose-limiting toxicities will be assessed according to the criteria specified in the protocol.
Time frame: From the first dose until 42 days
Phase I: Incidence and Severity of Adverse Events and Serious Adverse Events
The number and percentage of participants experiencing adverse events and serious adverse events, including their severity. The number and percentage of participants with clinically significant abnormalities in laboratory tests, 12-lead electrocardiograms, physical examinations, and vital signs.
Time frame: Up to 18 months
Phase II: Progression-Free Survival (PFS) Assessed by Independent Review Committee (IRC) per RECIST 1.1
The time from randomisation/enrolment/first treatment to the first documented disease progression or death from any cause, whichever occurs first, as assessed by the Independent Review Committee (IRC) according to RECIST version 1.1.
Time frame: Up to 18 months
Phase I: Progression-Free Survival
The time from randomisation/enrolment/first treatment to the first documented disease progression or death from any cause, whichever occurs first. Tumour response will be assessed according to RECIST version 1.1.
Time frame: Up to 18 months
Phase I: Objective Response Rate
The percentage of participants with a best overall response of complete response or partial response according to RECIST version 1.1.
Time frame: Up to 18 months
Phase I: Disease Control Rate
The percentage of participants with a best overall response of complete response, partial response, or stable disease according to RECIST version 1.1.
Time frame: Up to 18 months
Phase I: Duration of Response
The time from the first documented response to the first documented disease progression or death from any cause, whichever occurs first. Assessments will be performed according to RECIST version 1.1.
Time frame: Up to 18 months
Phase I: Time to Progression
The time from randomisation/enrolment/ the first treatment to the first documented disease progression according to RECIST version 1.1.
Time frame: Up to 18 months
Phase I: One-Year Overall Survival Rate
The probability of participants remaining alive at 1 year after enrolment.
Time frame: From enrolment until 1 year
Phase I: Overall Survival
The time from randomisation/enrolment/ the first dose to death from any cause.
Time frame: Up to 18 months
Phase I: Tumour Markers
Change from baseline in serum carbohydrate antigen 19-9 (CA199), carcinoembryonic antigen (CEA), and carbohydrate antigen 125 (CA 125) levels.
Time frame: Up to 18 months
Phase I: Quality of Life Change From Baseline Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Change from baseline in health-related quality of life in participants, measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The QLQ-C30 comprises functional scales, symptom scales and a global health status/quality of life scale. Higher scores on the functional scales and global health status/quality of life scale indicate better quality of life; higher scores on the symptom scales indicate worse symptoms.
Time frame: Up to 18 months
Phase I: Pancreatic Cancer-Specific Quality of Life Change From Baseline Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic Cancer Module 26 (EORTC QLQ-PAN26).
Change from baseline in pancreatic cancer-specific quality of life, measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic Cancer Module 26 (EORTC QLQ-PAN26). Higher scores on symptom scales indicate worse symptoms.
Time frame: Up to 18 months
Phase I: Fatigue Change From Baseline Measured by the Brief Fatigue Inventory (BFI)
Change from baseline in fatigue severity, measured using the Brief Fatigue Inventory (BFI). The BFI assesses the severity and impact of fatigue on daily functioning over the past 24 hours, with each item scored on a numeric scale from 0 (no fatigue) to 10 (fatigue as bad as you can imagine). Higher scores indicate more severe fatigue.
Time frame: Up to 18 months
Phase I:Pain Change From Baseline Measured by the Numeric Rating Scale (NRS)
Change from baseline in pain intensity, measured using the Pain Numeric Rating Scale (NRS). The NRS assesses pain severity over the past 24 hours, with participants rating pain on a numeric scale from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate more severe pain.
Time frame: Up to 18 months
Phase I: Maximum Observed Peripheral Blood iNKT-Cell Concentration (Cmax)
Pharmacokinetic Parameters
Time frame: Up to 6 months
Phase I: Time to Maximum Peripheral Blood iNKT-Cell Concentration (Tmax)
Pharmacokinetic Parameters
Time frame: Up to 6 months
Phase I: Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Time Point (AUC0-t)
Pharmacokinetic Parameters
Time frame: Up to 6 months
Phase I: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf)
Pharmacokinetic Parameters
Time frame: Up to 6 months
Phase I: Peripheral Immune-Cell Subsets Change From Baseline
Pharmacodynamic Parameters. Change from baseline in peripheral immune-cell subsets, including natural killer cells (CD3-negative/CD56-positive), activated natural killer cells (CD3-negative/CD56-positive/CD69-positive), CD8-positive T cells, and myeloid-derived suppressor cells (CD11b-positive/CD33-positive).
Time frame: Up to 6 months
Phase I: Plasma Cytokines and Other Soluble Biomarkers Change From Baseline
Change from baseline in plasma concentrations of interferon gamma, perforin, granzyme B, tumour necrosis factor alpha, granulocyte colony-stimulating factor, interleukin-1 beta, interleukin-2, interleukin-4, interleukin-5, interleukin-6, interleukin-8, interleukin-10, interleukin-12p70, interleukin-13, and interleukin-17.
Time frame: Up to 6 months
Phase II: Progression-Free Survival
The time from randomisation/enrolment/first treatment to the first documented disease progression or death from any cause, whichever occurs first. Tumour response will be assessed according to RECIST version 1.1.
Time frame: Up to 18 months
Phase II: Objective Response Rate
The percentage of participants with a best overall response of complete response or partial response according to RECIST version 1.1.
Time frame: Up to 18 months
Phase II: Disease Control Rate
The percentage of participants with a best overall response of complete response, partial response, or stable disease according to RECIST version 1.1.
Time frame: Up to 18 months
Phase II: Duration of Response
The time from the first documented response to the first documented disease progression or death from any cause, whichever occurs first. Assessments will be performed according to RECIST version 1.1.
Time frame: Up to 18 months
Phase II: Time to Progression
The time from randomisation/enrolment/ the first treatment to the first documented disease progression according to RECIST version 1.1.
Time frame: Up to 18 months
Phase II: One-Year Overall Survival Rate
The probability of participants remaining alive at 1 year after enrolment.
Time frame: From enrolment until 1 year
Phase II: Overall Survival
The time from randomisation/enrolment/ the first dose to death from any cause.
Time frame: Up to 18 months
Phase II: Tumour Markers
Change from baseline in serum carbohydrate antigen 19-9 (CA199), carcinoembryonic antigen (CEA), and carbohydrate antigen 125 (CA 125) levels.
Time frame: Up to 18 months
Phase II:Quality of Life Change From Baseline Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Change from baseline in health-related quality of life in participants, measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The QLQ-C30 comprises functional scales, symptom scales and a global health status/quality of life scale. Higher scores on the functional scales and global health status/quality of life scale indicate better quality of life; higher scores on the symptom scales indicate worse symptoms.
Time frame: Up to 18 months
Phase II: Pancreatic Cancer-Specific Quality of Life Change From Baseline Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic Cancer Module 26 (EORTC QLQ-PAN26).
Change from baseline in pancreatic cancer-specific quality of life, measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic Cancer Module 26 (EORTC QLQ-PAN26). Higher scores on symptom scales indicate worse symptoms.
Time frame: Up to 18 months
Phase II: Fatigue Change From Baseline Measured by the Brief Fatigue Inventory (BFI)
Change from baseline in fatigue severity, measured using the Brief Fatigue Inventory (BFI). The BFI assesses the severity and impact of fatigue on daily functioning over the past 24 hours, with each item scored on a numeric scale from 0 (no fatigue) to 10 (fatigue as bad as you can imagine). Higher scores indicate more severe fatigue.
Time frame: Up to 18 months
Phase II:Pain Change From Baseline Measured by the Numeric Rating Scale (NRS)
Change from baseline in pain intensity, measured using the Pain Numeric Rating Scale (NRS). The NRS assesses pain severity over the past 24 hours, with participants rating pain on a numeric scale from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate more severe pain.
Time frame: Up to 18 months
Phase II: Incidence and Severity of Adverse Events and Serious Adverse Events
The number and percentage of participants experiencing adverse events and serious adverse events, including their severity. The number and percentage of participants with clinically significant abnormalities in laboratory tests, 12-lead electrocardiograms, physical examinations, and vital signs.
Time frame: Up to 18 months
Phase II: Maximum Observed Peripheral Blood iNKT-Cell Concentration (Cmax)
Pharmacokinetic Parameters
Time frame: Up to 6 months
Phase II: Time to Maximum Peripheral Blood iNKT-Cell Concentration (Tmax)
Pharmacokinetic Parameters
Time frame: Up to 6 months
Phase II: Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Time Point (AUC0-t)
Pharmacokinetic Parameters
Time frame: Up to 6 months
Phase II: Peripheral Immune-Cell Subsets Change From Baseline
Pharmacodynamic Parameters. Change from baseline in peripheral immune-cell subsets, including natural killer cells (CD3-negative/CD56-positive), activated natural killer cells (CD3-negative/CD56-positive/CD69-positive), CD8-positive T cells, and myeloid-derived suppressor cells (CD11b-positive/CD33-positive).
Time frame: Up to 6 months
Phase II: Plasma Cytokines and Other Soluble Biomarkers Change From Baseline
Change from baseline in plasma concentrations of interferon gamma, perforin, granzyme B, tumour necrosis factor alpha.
Time frame: Up to 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Mar 2027, 19 months after the start.
Of 115 industry-sponsored phase 1/2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 88. This study's planned 19 months is below that.
Counting every sponsor, half of 209 studies reached it within 51 months; a quarter within 36 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: GKL-006
Beijing Gene Key Life Technology Co., Ltd →