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New treatment option for Borderline Resectable Pancreatic Adenocarcinoma
Official title HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation
ClinicalTrials.gov ID: NCT07240766
What this study is testing
What is HRS-4642+AG+Nimotuzumab?
HRS-4642+AG+Nimotuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for borderline resectable pancreatic adenocarcinoma.
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 is a Phase II clinical trial that plans to enroll 40 patients with borderline resectable pancreatic cancer harboring a KRAS G12D mutation, aiming to evaluate the efficacy of HRS-4642 in combination with Nimotuzumab and AG in borderline resectable pancreatic cancer. The study process includes a screening period (from the signing of the informed consent form until the first dose), a treatment period (from the first dose to the discontinuation of study treatment), and a follow-up period (safety follow-up and survival follow-up after the discontinuation of study treatment).
- 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
- Aged between 18 and 75 years (inclusive).
- Histopathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium).
- Radiologically confirmed borderline resectable pancreatic cancer (according to the latest NCCN guidelines definition), with no distant metastases.
- Tumor tissue testing confirms KRAS G12D mutation.
- No prior systemic anti-tumor therapy.
You likely can't join if
- 1\. Prior Treatment:
- Major surgical procedure or significant traumatic injury within 4 weeks prior to enrollment, or palliative local therapy (including but not limited...
- Treatment with any investigational drug from another clinical study within 4 weeks prior to enrollment, except for participation in an observational...
- Use of strong inhibitors or inducers of hepatic drug-metabolizing enzymes CYP3A4 or CYP2C8 within 14 days prior to enrollment.
- 2\. Acute or chronic pancreatitis requiring clinical intervention.
- 3\. History or presence of symptoms/signs of gastrointestinal obstruction within 6 months prior to the start of study treatment. people may be...
See the full eligibility criteria
Who can join
- Aged between 18 and 75 years (inclusive).
- Histopathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium).
- Radiologically confirmed borderline resectable pancreatic cancer (according to the latest NCCN guidelines definition), with no distant metastases.
- Tumor tissue testing confirms KRAS G12D mutation.
- No prior systemic anti-tumor therapy.
- At least one evaluable lesion according to RECIST v1.1 criteria.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.
- Expected survival time ≥ 3 months.
- Adequate organ function meeting the following requirements (no use of any blood components or colony-stimulating factors within 2 weeks prior to enrollment):
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Platelets ≥ 80 × 10⁹/L
- Hemoglobin ≥ 100 g/L
- Serum albumin ≥ 30 g/L
- Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN and ALP ≤ 2.5 × ULN
- Creatinine clearance ≥ 50 mL/min or Serum creatinine ≤ 1.5 × ULN (Calculation formula see section 13.3)
- Electrocardiogram: QTcF ≤ 450 ms (male), QTcF ≤ 470 ms (female)
- Cardiac ultrasound: LVEF (Left Ventricular Ejection Fraction) ≥ 50%
- Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment, must be non-lactating, and must be willing to use adequate contraception during the trial and for 6 months after...
- Voluntary participation in this study and signing of informed consent, good compliance, and agreement to cooperate with follow-up.
What rules you out
- 1\. Prior Treatment:
- Major surgical procedure or significant traumatic injury within 4 weeks prior to enrollment, or palliative local therapy (including but not limited to palliative radiotherapy, treatment therapy) within 2 weeks prior to...
- Treatment with any investigational drug from another clinical study within 4 weeks prior to enrollment, except for participation in an observational (non-treatment) clinical study or the follow-up phase of an treatment...
- Use of strong inhibitors or inducers of hepatic drug-metabolizing enzymes CYP3A4 or CYP2C8 within 14 days prior to enrollment.
- 2\. Acute or chronic pancreatitis requiring clinical intervention.
- 3\. History or presence of symptoms/signs of gastrointestinal obstruction within 6 months prior to the start of study treatment. people may be screened if they have undergone surgical procedure resulting in complete...
- 4\. Third-space fluid accumulation (e.g., significant pleural effusion, ascites, etc.) that is unstable (unable to remain stable without intervention after drainage removal) within 2 weeks prior to enrollment. people...
- 5\. Severe infection within 4 weeks prior to enrollment, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; Unexplained fever \>38.5°C within 2 weeks prior to enrollment (people...
- 6\. Severe cardiovascular and cerebrovascular diseases:
- Important arterial/venous thrombotic events within 6 months prior to enrollment, such as cerebrovascular accident (including cerebral hemorrhage, cerebral infarction), deep vein thrombosis (excluding muscular venous...
- Poorly controlled cardiac symptoms or diseases, such as:
- Myocardial infarction within 6 months.
- Unstable angina.
- Heart failure of NYHA class II or above.
- people with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
- 7\. Patients with known or suspected interstitial lung disease, with the exception of interstitial changes visible only on imaging without clinical symptoms.
- 8\. History of definite neurological or psychiatric disorders, including epilepsy and dementia.
- 9\. Presence of non-healed wounds (severe, non-healing, or dehisced) or unhealed fractures.
- 10\. Adverse events from prior anti-cancer therapy have not recovered to NCI-CTCAE grade ≤1 (except for alopecia and parameters already specified in the inclusion criteria; except for AEs judged by the investigator as...
- 11\. History of other malignant tumors within 5 years prior to enrollment, except for those with low risk of metastasis and death: adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin...
- 12\. Concurrent active Hepatitis B (if HBsAg positive, HBV DNA must be tested; HBV DNA \<2000 IU/mL is required for enrollment and the subject must receive standard antiviral therapy during the study), Hepatitis C (HCV...
- 13\. Known allergy to any component of HRS-4642; history of allergy to Nimotuzumab, other monoclonal antibody/fusion protein drugs, albumin-bound paclitaxel, or gemcitabine.
- 14\. Any other condition that, in the judgment of the investigator, may affect the study results or lead to the premature termination of the study, such as alcoholism, drug abuse, other serious concomitant diseases...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Hangzhou, Zhejiang, 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.