Advanced Pancreatic CancerPhase 1/2NCT07777211
A Study of GKL-006 Injection in Patients With Advanced Pancreatic Cancer
A Phase 1/2 study testing GKL-006 injection and Nab-paclitaxel and Gemcitabine in people with Advanced Pancreatic Cancer and Ductal Adenocarcinoma of Pancreas, run by Beijing Gene Key Life Technology Co., Ltd at 1 site in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Pancreatic Cancer, Ductal Adenocarcinoma of Pancreas
- What is being tested?
- GKL-006 injection and Nab-paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 14 Aug 2025to 31 Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Known hypersensitivity to any component of the study treatments.
- Other unresolved malignancy within 5 years or concurrently, except specified adequately treated malignancies.
- 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.
- Known brain or meningeal metastases, except stable brain metastases.
- Symptomatic ascites or pleural effusion.
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- 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.
- 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.
- History or presence of tumour-related GI obstruction requiring treatment.
- Active systemic infection requiring treatment within 2 weeks, or unexplained fever or clinically significant leukocytosis within 7 days before enrolment.
- Congenital or acquired immunodeficiency, active syphilis or another serious active infection, or HBV/HCV infection with detectable viral load at screening.
- Any contraindication to IL-2.
- Prior genetically modified cell therapy, or non-genetically modified cell therapy within 6 months before screening.
- Pregnancy or breastfeeding.
- Receipt of an attenuated vaccine or participation in another drug/device clinical study within 4 weeks before screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
No. 1 Shuaifuyuan, Wangfujing, Dongcheng District
Beijing, Beijing Municipality, 100010
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- GKL-006 injection, Nab-paclitaxel and Gemcitabine
- Keywords
- GKL-006, iNKT cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GKL-006 injectionBiological
Also called GKL-006
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.
Nab-paclitaxel and GemcitabineDrug
Also called nab-P+G, AG
Nab-paclitaxel and Gemcitabine are given intravenously as a combination chemotherapy regimen according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Low-Dose Cohort | Experimental | Low-Dose GKL-006 injection plus AG regimen Receives: Biological: GKL-006 injection; Drug: Nab-paclitaxel and Gemcitabine |
| Phase I High-Dose Cohort | Experimental | High-Dose GKL-006 injection plus AG regimen Receives: Biological: GKL-006 injection; Drug: Nab-paclitaxel and Gemcitabine |
| Phase II Investigational Arm | Experimental | Selected dose level of GKL-006 injection from phase I plus AG regimen Receives: Biological: GKL-006 injection; Drug: Nab-paclitaxel and Gemcitabine |
| Phase II Control Arm | Active comparator | AG regimen, Nab-paclitaxel and gemcitabine per protocol Receives: Drug: Nab-paclitaxel and Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 18 months
Secondary outcomes (36)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 18 months
Phase I: One-Year Overall Survival Rate
The probability of participants remaining alive at 1 year after enrolment.
Measured: From enrolment until 1 year
Phase I: Overall Survival
The time from randomisation/enrolment/ the first dose to death from any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 18 months
Phase I: Maximum Observed Peripheral Blood iNKT-Cell Concentration (Cmax)
Pharmacokinetic Parameters
Measured: Up to 6 months
Phase I: Time to Maximum Peripheral Blood iNKT-Cell Concentration (Tmax)
Pharmacokinetic Parameters
Measured: 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
Measured: Up to 6 months
Phase I: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf)
Pharmacokinetic Parameters
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 18 months
Phase II: One-Year Overall Survival Rate
The probability of participants remaining alive at 1 year after enrolment.
Measured: From enrolment until 1 year
Phase II: Overall Survival
The time from randomisation/enrolment/ the first dose to death from any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 18 months
Phase II: Maximum Observed Peripheral Blood iNKT-Cell Concentration (Cmax)
Pharmacokinetic Parameters
Measured: Up to 6 months
Phase II: Time to Maximum Peripheral Blood iNKT-Cell Concentration (Tmax)
Pharmacokinetic Parameters
Measured: 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
Measured: 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).
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start14 Aug 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two sequential parts. In Phase I, participants will be enrolled sequentially into a low-dose cohort followed by a high-dose cohort. In Phase II, participants will be assigned in parallel to the investigational arm or the control arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Gene Key Life Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777211
- Sponsor's protocol ID
- GKL006PDA01
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of GKL-006 Injection in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07777211
- Acronym / sponsor ID
- GKL006PDA01
- Keywords
- GKL-006, iNKT cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Beijing Gene Key Life Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- The study consists of two sequential parts. In Phase I, participants will be enrolled sequentially into a low-dose cohort followed by a high-dose cohort. In Phase II, participants will be assigned in parallel to the investigational arm or the control arm.
| Arm | Type | Receives |
|---|---|---|
| Phase I Low-Dose Cohort | Experimental | Biological: GKL-006 injection, Drug: Nab-paclitaxel and GemcitabineLow-Dose GKL-006 injection plus AG regimen |
| Phase I High-Dose Cohort | Experimental | Biological: GKL-006 injection, Drug: Nab-paclitaxel and GemcitabineHigh-Dose GKL-006 injection plus AG regimen |
| Phase II Investigational Arm | Experimental | Biological: GKL-006 injection, Drug: Nab-paclitaxel and GemcitabineSelected dose level of GKL-006 injection from phase I plus AG regimen |
| Phase II Control Arm | Active comparator | Drug: Nab-paclitaxel and GemcitabineAG regimen, Nab-paclitaxel and gemcitabine per protocol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- Known hypersensitivity to any component of the study treatments.
- Other unresolved malignancy within 5 years or concurrently, except specified adequately treated malignancies.
- 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.
- Known brain or meningeal metastases, except stable brain metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GKL-006 injectionAlso: GKL-006GKL-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. | Biological | Phase I High-Dose Cohort, Phase I Low-Dose Cohort, Phase II Investigational Arm |
| Nab-paclitaxel and GemcitabineAlso: nab-P+G, AGNab-paclitaxel and Gemcitabine are given intravenously as a combination chemotherapy regimen according to the study protocol. | Drug | Phase I High-Dose Cohort, Phase I Low-Dose Cohort, Phase II Control Arm, Phase II Investigational Arm |
Primary outcome
Phase I: Incidence of Dose-Limiting Toxicities
Time frame: From the first dose until 42 days
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.
Phase I: Incidence and Severity of Adverse Events and Serious Adverse Events
Time frame: Up to 18 months
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.
Phase II: Progression-Free Survival (PFS) Assessed by Independent Review Committee (IRC) per RECIST 1.1
Time frame: Up to 18 months
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.
36 secondary outcomes
Phase I: Progression-Free Survival
Time frame: Up to 18 months
Phase I: Objective Response Rate
Time frame: Up to 18 months
Phase I: Disease Control Rate
Time frame: Up to 18 months
Phase I: Duration of Response
Time frame: Up to 18 months
Phase I: Time to Progression
Time frame: Up to 18 months
Phase I: One-Year Overall Survival Rate
Time frame: From enrolment until 1 year
Phase I: Overall Survival
Time frame: Up to 18 months
Phase I: Tumour Markers
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)
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).
Time frame: Up to 18 months
Phase I: Fatigue Change From Baseline Measured by the Brief Fatigue Inventory (BFI)
Time frame: Up to 18 months
Phase I:Pain Change From Baseline Measured by the Numeric Rating Scale (NRS)
Time frame: Up to 18 months
Phase I: Maximum Observed Peripheral Blood iNKT-Cell Concentration (Cmax)
Time frame: Up to 6 months
Phase I: Time to Maximum Peripheral Blood iNKT-Cell Concentration (Tmax)
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)
Time frame: Up to 6 months
Phase I: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf)
Time frame: Up to 6 months
Phase I: Peripheral Immune-Cell Subsets Change From Baseline
Time frame: Up to 6 months
Phase I: Plasma Cytokines and Other Soluble Biomarkers Change From Baseline
Time frame: Up to 6 months
Phase II: Progression-Free Survival
Time frame: Up to 18 months
Phase II: Objective Response Rate
Time frame: Up to 18 months
Phase II: Disease Control Rate
Time frame: Up to 18 months
Phase II: Duration of Response
Time frame: Up to 18 months
Phase II: Time to Progression
Time frame: Up to 18 months
Phase II: One-Year Overall Survival Rate
Time frame: From enrolment until 1 year
Phase II: Overall Survival
Time frame: Up to 18 months
Phase II: Tumour Markers
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)
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).
Time frame: Up to 18 months
Phase II: Fatigue Change From Baseline Measured by the Brief Fatigue Inventory (BFI)
Time frame: Up to 18 months
Phase II:Pain Change From Baseline Measured by the Numeric Rating Scale (NRS)
Time frame: Up to 18 months
Phase II: Incidence and Severity of Adverse Events and Serious Adverse Events
Time frame: Up to 18 months
Phase II: Maximum Observed Peripheral Blood iNKT-Cell Concentration (Cmax)
Time frame: Up to 6 months
Phase II: Time to Maximum Peripheral Blood iNKT-Cell Concentration (Tmax)
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)
Time frame: Up to 6 months
Phase II: Peripheral Immune-Cell Subsets Change From Baseline
Time frame: Up to 6 months
Phase II: Plasma Cytokines and Other Soluble Biomarkers Change From Baseline
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GKL-006 injection and Nab-paclitaxel and Gemcitabine in people with Advanced Pancreatic Cancer and Ductal Adenocarcinoma of Pancreas, run by Beijing Gene Key Life Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical trial ethics committee subject reception (+86-10-69154186, tpingzhang@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Incidence of Dose-Limiting Toxicities (time frame: From the first dose until 42 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.