BridgeMD
New treatment option for Locally Advanced Pancreatic Cancer With KRAS G12D Mutation
Official title A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT07438106
What this study is testing
What is HRS-4642 Injection?
HRS-4642 Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced pancreatic cancer with kras g12d mutation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the effectiveness and safety of HRS-4642 in combination with nab-paclitaxel and gemcitabine (AG regimen) as conversion therapy for patients with locally advanced pancreatic cancer. Participants will undergo regular assessments, including imaging scans and CA19-9 biomarker tests.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants must meet all of the following criteria to be eligible for this study:
- Age ≥18 years and ≤75 years, regardless of gender.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
- Radiologically confirmed locally advanced disease, defined as:
- No distant metastasis.
You likely can't join if
- Participants will be excluded from the study if they meet any of the following criteria:
- Presence of portal hypertension or cavernous transformation of the portal vein; tumor involvement of the gastrointestinal tract causing...
- Diagnosis of malignancies other than pancreatic cancer within 5 years prior to the first dose (excluding radically treated skin basal cell carcinoma...
- History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2...
- Current use of systemic corticosteroid therapy (excluding topical, inhaled, nasal, or intra-articular corticosteroids) or any other form of...
- Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
See the full eligibility criteria
Who can join
- Participants must meet all of the following criteria to be eligible for this study:
- Age ≥18 years and ≤75 years, regardless of gender.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
- Radiologically confirmed locally advanced disease, defined as:
- No distant metastasis.
- Pancreatic head/uncinate process tumors: Tumor contact with the superior mesenteric artery (SMA) \>180°.
- Pancreatic body/tail tumors: Tumor contact with the SMA or celiac artery \>180°; or contact with the celiac artery with aortic invasion; or tumor invasion of the jejunal branches of the SMA.
- Inability to safely reconstruct the portal vein-superior mesenteric vein due to tumor invasion, venous occlusion, or extensive involvement of the jejunal branches of the superior mesenteric vein.
- KRAS G12D mutation confirmed by tissue histology or peripheral blood testing.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- No prior antitumor therapy (including radiotherapy, chemotherapy, targeted therapy, or immunotherapy).
- At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- If biliary obstruction is present, it must have been relieved prior to study entry, and the expected survival time is \>3 months.
- Signed written informed consent obtained before performing any study-related procedures.
- Adequate organ function meeting the following criteria (without corrective treatment with blood components or growth factors within 14 days prior to the first dose), with test results completed within 7 days before...
- Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L.
- White blood cell (WBC) count ≥3.0 × 10\^9/L.
- Platelets ≥100 × 10\^9/L.
- Hemoglobin \>9 g/dL.
- Albumin ≥3.0 g/dL.
- Total bilirubin ≤1.5 × upper limit of normal (ULN).
- Prothrombin time and activated partial thromboplastin time ≤1.5 × ULN.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.
- Serum creatinine ≤1.5 × ULN or creatinine clearance (calculated using Cockcroft-Gault formula) ≥50 mL/min.
- Electrocardiogram: QTcF interval ≤450 msec for males and ≤470 msec for females.
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must not be lactating. Female participants of childbearing potential and male participants...
What rules you out
- Participants will be excluded from the study if they meet any of the following criteria:
- Presence of portal hypertension or cavernous transformation of the portal vein; tumor involvement of the gastrointestinal tract causing gastrointestinal bleeding; tumor leading to intra-abdominal fistula or abscess...
- Diagnosis of malignancies other than pancreatic cancer within 5 years prior to the first dose (excluding radically treated skin basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ).
- History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine...
- Current use of systemic corticosteroid therapy (excluding topical, inhaled, nasal, or intra-articular corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. Note...
- Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- History of allergy or hypersensitivity considered clinically significant by the investigator.
- Presence of clinically significant acute or chronic pancreatitis.
- History of drug abuse, chronic alcoholism, or infectious diseases such as AIDS (i.e., HIV-1/2 antibody positive).
- Uncontrolled active hepatitis B (defined as HBsAg positive with HBV-DNA level above the upper limit of normal at the local laboratory). Note: Participants with hepatitis B meeting the following criteria may be enrolled...
- Active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA level above the lower limit of detection).
- Administration of a live attenuated vaccine within 28 days prior to the first study dose or anticipated need for a live attenuated vaccine during the study treatment period. Note: Administration of inactivated seasonal...
- Major surgery (other than diagnostic biopsy) within 28 days prior to the first dose; minor traumatic surgery (biopsy, endoscopy, and drainage) within 7 days prior to the first dose; presence of non-healing wounds...
- Presence of any severe or uncontrolled systemic disease, for example:
- Resting ECG showing significant uncontrolled abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or...
- Unstable angina, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) class ≥II.
- History of any arterial thrombotic, embolic, or ischemic event within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
- Poorly controlled blood pressure (systolic \>150 mmHg or diastolic \>100 mmHg).
- History of non-infectious interstitial lung disease requiring glucocorticoid therapy within 1 year prior to the first dose, or current clinically active interstitial lung disease.
- Active tuberculosis.
- Active or uncontrolled infection requiring systemic therapy.
- Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- Liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis.
- Low-density lipoprotein cholesterol (LDL-C) \>3.4 mmol/L or severe hypertriglyceridemia (\>5.7 mmol/L).
- Carotid ultrasound showing stenosis ≥50% or the presence of two or more high-risk characteristic plaques.
- History of severe infection within 28 days prior to the first dose, including but not limited to infection complications requiring hospitalization, bacteremia, or severe pneumonia; or active infection requiring...
- Any history, evidence of disease, treatment, or abnormal laboratory value that, in the investigator's judgment, could interfere with the trial results, prevent the participant from completing the study, indicate poor...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.