Pancreatic Cancer Non-resectablePhase 4NCT07302841
Tunlametinib + AG + Cetuximab β as First-Line Therapy for Advanced Pancreatic Cancer
A Phase 4 study testing Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β in people with Pancreatic Cancer Non-resectable, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
This study is a prospective, open-label, single-arm clinical trial evaluating the safety and efficacy of tunlametinib in combination with gemcitabine/albumin-bound paclitaxel and an EGFR monoclonal antibody as first-line therapy in treatment-naive subjects with advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Non-resectable
- What is being tested?
- Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 30 Dec 2028
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing of a written informed consent form prior to enrolment;
- Age > 18 years, males and females eligible;
- Patients with histologically or pathologically confirmed advanced pancreatic cancer;
- No prior systemic therapy;
- At least one measurable lesion according to RECIST v1.1 assessment;
- ECOG Performance Status: 0-1;
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- Expected survival greater than 12 weeks;
- Major organ function meeting the following requirements:
- Haemogram: Neutrophils ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Haemoglobin ≥ 90 g/L; Maintenance of these haematological parameters without G-CSF, platelet transfusion, TPO infusion, blood transfusion, or erythropoietin support for 14 days prior to first dose.
- Hepatic and Renal Function: Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≤ 5 times ULN; Urine protein <2+; if urine protein ≥2+, 24-hour urine protein quantification must show protein ≤1g;
- Creatine kinase (CK) ≤ 1.5 × ULN
- Normal coagulation function with no active bleeding or thrombotic disorders: International Normalised Ratio (INR) ≤ 1.5 × ULN; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; Prothrombin Time (PT) ≤ 1.5 × ULN;
- Non-surgically sterilised or female patients of childbearing potential must use one medically approved contraceptive method (e.g., intrauterine device, oral contraceptive, condom) during study treatment and for 3 months post-treatment. Non-surgically sterilised female patients of childbearing potential must have negative serum or urinary hCG tests within 7 days prior to study entry and must not be lactating. Male subjects who are not surgically sterilised or who are of reproductive age must agree to use one medically approved contraceptive method with their partner during the study treatment period and for 3 months after the study treatment period.
- Able to take oral medication;
- The subject voluntarily participates in this study, demonstrates good compliance, and cooperates with safety and survival follow-up.
Who cannot join
- Known contraindications affecting the investigator's choice of therapeutic agent (as per the latest prescribing information)
- Receipt of any other investigational treatment within 4 weeks prior to study dosing initiation;
- Undergoing major surgery (excluding biopsy, minor outpatient procedures such as vascular access placement) or experiencing severe trauma within 4 weeks prior to first dosing, or having scheduled major surgery within 30 days after first dosing (as determined by the investigator);
- Previous receipt of anti-EGFR monoclonal antibodies, EGFR tyrosine kinase inhibitors, or other EGFR-targeted therapies (e.g., cetuximab, nintedanib, panitumumab);
- Presence of clinically symptomatic third-space effusions uncontrollable by drainage or other methods (e.g., massive pleural effusion or ascites);
- Symptomatic or untreated brain metastases, leptomeningeal metastases, or spinal cord compression, except for asymptomatic brain metastases (i.e., no progressive CNS symptoms attributable to brain lesions, no requirement for corticosteroids or antiepileptic drugs, and imaging confirmation of stable disease for ≥4 weeks); Patients undergoing stereotactic brain radiotherapy or surgery may be eligible if no disease progression is observed in the brain over a period of ≥3 months;
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- Cardiac impairment or clinically significant cardiovascular disease with uncontrolled cardiac symptoms or conditions, such as: (1) NYHA Class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
- History or presence at screening of retinal disease, including: retinal vein occlusion (RVO), retinal artery occlusion, retinal vasculitis, diabetic retinopathy, hypertensive retinopathy, retinal capillaropathy (Costs disease), retinal pigment epithelial detachment (RPED); Presence of RVO risk factors at screening (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulable syndromes); retinal diseases such as RPED;
- Patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring intervention);
- Known active pulmonary tuberculosis (TB); subjects suspected of active TB must undergo clinical evaluation to rule it out; known active syphilis infection;
- Human immunodeficiency virus (HIV) antibody positive, syphilis antibody (Anti-TP) positive, hepatitis C virus (HCV) antibody positive with HCV RNA positive, hepatitis B virus surface antigen (HBsAg) positive with HBV DNA positive (HBsAg positive requires further testing for HBV DNA, HBV DNA ≥ 200 IU/ml, or ≥ 10³ copies/ml);
- History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulators or surgery) within 12 months prior to treatment initiation;
- Known history of acute or chronic pancreatitis within 6 months prior to study treatment initiation;
- History of allogeneic bone marrow transplantation or organ transplantation;
- Uncontrolled active infectious disease requiring intravenous antibiotics, antifungals, or antivirals within 2 weeks prior to first dosing, or unexplained fever >38.5°C during screening/prior to first dosing;
- Uncorrectable electrolyte abnormalities (hypokalaemia, hypomagnesaemia, hypocalcaemia confirmed by blood biochemistry);
- Past or current neuromuscular disorders associated with elevated CK levels (e.g., inflammatory myopathies, muscular dystrophies, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis syndrome);
- Arterial or venous thromboembolic events occurring within 6 months prior to first administration, such as cerebrovascular accidents (including transient ischaemic attacks, cerebral haemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
- Presence of oesophageal or gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, intra-abdominal abscess, or history of acute gastrointestinal haemorrhage within 6 months prior to first administration; occurrence of hypertensive crisis or hypertensive encephalopathy within 6 months prior to first administration; acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to first administration;
- Grade 3 bleeding events as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) within 4 weeks prior to first dosing;
- History of severe bleeding tendency or coagulation disorders; screening imaging demonstrating tumour encasement of major vessels or significant necrosis/cavitation, where the investigator deems participation may pose a bleeding risk;
- Current radiographic or clinical evidence of significant gastrointestinal obstruction;
- History of other malignancies within the past 5 years, except for patients with completely cured basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ, and/or any malignancy that has been cured with no evidence of disease or at least 5 years of continuous disease-free status;
- Known allergy to any component of the study drug;
- History of defined neurological or psychiatric disorders, including epilepsy and dementia;
- Failure of all relevant antineoplastic treatment toxicities to recover to Grade ≤1 (as assessed per NCI CTCAE V5.0) prior to study drug administration;
- Concurrent use of other antineoplastic agents for concomitant therapy (bisphosphonates for bone metastases are acceptable);
- Uncontrolled concomitant conditions, including but not limited to severe diabetes mellitus (fasting blood glucose > 250 mg/dl or 13.9 mmol/L) or other serious illnesses requiring systemic treatment;
- Recipient of live or attenuated vaccines within 4 weeks prior to first dosing (Note: If enrolled, subjects must not receive live vaccines during study treatment or within 30 days after the last study drug dose);
- Positive pregnancy test results in premenopausal female subjects (postmenopausal female subjects must have been amenorrheic for at least 12 months to be considered non-fertile); subjects of reproductive age (including female partners of male subjects) who are likely to become pregnant, are breastfeeding, or are unwilling to use effective contraception during the study period and for at least 30 days after the last dose of study medication;
- Patients currently receiving intravenous or oral medications that are prohibited by the protocol due to their effects on CYP isoenzymes (strong inducers or inhibitors of CYP2C9 and CYP3A4) and cannot be discontinued at least one week prior to study treatment initiation and throughout the study period; patients taking narrow therapeutic index medications metabolised via CYP1A2;
- Inability to swallow capsules, or refractory nausea and vomiting, malabsorption, extrahepatic bile diversion, or significant small bowel resection that may impair adequate absorption of the study drug;
- Other circumstances deemed unsuitable for inclusion by the investigator. For example, family or social factors that may compromise the subject's safety or the collection of data and samples.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study Evaluating the Efficacy and Safety of Tunlametinib in Combination With Chemotherapy and Cetuximab β in Patients With Advanced Pancreatic Cancer
This study is a prospective, open-label, single-arm clinical trial evaluating the safety and efficacy of tunlametinib in combination with gemcitabine/albumin-bound paclitaxel and an EGFR monoclonal antibody as first-line therapy in treatment-naive subjects with advanced pancreatic cancer.
- Conditions
- Pancreatic Cancer Non-resectable
- Being tested
- Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β
- Keywords
- first-line therapy in treatment, MEK inhibitor, AG, Tunlametinib, Cetuximab β
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab βDrug
Tunlametinib + Gemcitabine + Albumin Paclitaxel + Cetuximab β. The dosage of Tunlametinib capsules is 9 mg, taken orally twice a day (BID), continuously administered; the dosage of Gemcitabine is 1000 mg/m2, intravenous infusion for more than 30 minutes, on days 1 and 8; Albumin Paclitaxel, 125 mg/m2, intravenous infusion, on days 1 and 8, with a cycle every 3 weeks; Cetuximab β: 500 mg/m², intravenous infusion, on day 1, with the injection duration exceeding 2 hours but not more than 4 hours, administered once every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β | Experimental | Not described Receives: Drug: Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Measured: 2 years
Secondary outcomes (5)
PFS
Measured: 2 years
DCR
Measured: 2 years
DOR
Measured: 2 years
AEs
Measured: 2 years
OS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start20 Jan 2026 (estimated)
- Primary completion20 Jun 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Non-resectableStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302841
- Sponsor's protocol ID
- IIT-085-ST-005
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Efficacy and Safety of Tunlametinib in Combination With Chemotherapy and Cetuximab β in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07302841
- Acronym / sponsor ID
- IIT-085-ST-005
- Conditions
- Pancreatic Cancer Non-resectable
- Keywords
- first-line therapy in treatment, MEK inhibitor, AG, Tunlametinib, Cetuximab β
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 24 Dec 2025 (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 study is a prospective, open-label, single-arm clinical trial evaluating the safety and efficacy of tunlametinib in combination with gemcitabine/albumin-bound paclitaxel and an EGFR monoclonal antibody as first-line therapy in treatment-naive subjects with advanced pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β | Experimental | Drug: Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signing of a written informed consent form prior to enrolment;
- Age > 18 years, males and females eligible;
- Patients with histologically or pathologically confirmed advanced pancreatic cancer;
- No prior systemic therapy;
- At least one measurable lesion according to RECIST v1.1 assessment;
Key exclusion criteria (33 listed)
- Known contraindications affecting the investigator's choice of therapeutic agent (as per the latest prescribing information)
- Receipt of any other investigational treatment within 4 weeks prior to study dosing initiation;
- Undergoing major surgery (excluding biopsy, minor outpatient procedures such as vascular access placement) or experiencing severe trauma within 4 weeks prior to first dosing, or having scheduled major surgery within 30 days after first dosing (as determined by the investigator);
- Previous receipt of anti-EGFR monoclonal antibodies, EGFR tyrosine kinase inhibitors, or other EGFR-targeted therapies (e.g., cetuximab, nintedanib, panitumumab);
- Presence of clinically symptomatic third-space effusions uncontrollable by drainage or other methods (e.g., massive pleural effusion or ascites);
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 |
|---|---|---|
| Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab βTunlametinib + Gemcitabine + Albumin Paclitaxel + Cetuximab β. The dosage of Tunlametinib capsules is 9 mg, taken orally twice a day (BID), continuously administered; the dosage of Gemcitabine is 1000 mg/m2, intravenous infusion for more than 30 minutes, on days 1 and 8; Albumin Paclitaxel, 125 mg/m2, intravenous infusion, on days 1 and 8, with a cycle every 3 weeks; Cetuximab β: 500 mg/m², intravenous infusion, on day 1, with the injection duration exceeding 2 hours but not more than 4 hours, administered once every 2 weeks. | Drug | Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β |
Primary outcome
ORR
Time frame: 2 years
5 secondary outcomes
PFS
Time frame: 2 years
DCR
Time frame: 2 years
DOR
Time frame: 2 years
AEs
Time frame: 2 years
OS
Time frame: 2 years
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 24 Dec 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental: Tunlametinib+gemcitabine+albumin paclitaxel + cetuximab β in people with Pancreatic Cancer Non-resectable, run by Tianjin Medical University Cancer Institute and Hospital.
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 15 inclusion and 33 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: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Rui Liu, MD (+86 13602139003, liurui9003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 2 years). 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 24 Dec 2025.