Actively Recruiting
HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation
Led by Zhejiang University · Updated on 2026-02-13
40
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years (inclusive)
- Histopathologically confirmed pancreatic cancer originating from the pancreatic ductal epithelium
- Radiologically confirmed borderline resectable pancreatic cancer with no distant metastases
- Tumor tissue confirmed to have KRAS G12D mutation
- No prior systemic anti-tumor therapy
- At least one evaluable lesion according to RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival time of at least 3 months
- Adequate organ function including: ANC 1.5 10/L, platelets 80 10/L, hemoglobin 100 g/L, serum albumin 30 g/L, total bilirubin 1.5 ULN, ALT and AST 3 ULN, ALP 2.5 ULN, creatinine clearance 50 mL/min or serum creatinine 1.5 ULN, QTcF 450 ms (male) or 470 ms (female), LVEF 50%
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment, be non-lactating, and agree to use contraception during and for 6 months after treatment
- Men must be surgically sterile or agree to use contraception during and for 6 months after treatment
- Voluntary participation with signed informed consent and agreement to follow-up
You will not qualify if you...
- Major surgery or significant injury within 4 weeks before enrollment, or palliative local therapy within 2 weeks before enrollment
- Participation in another investigational drug study within 4 weeks before enrollment, except observational studies or follow-up phases
- Use of strong CYP3A4 or CYP2C8 inhibitors/inducers within 14 days before enrollment
- Acute or chronic pancreatitis requiring treatment
- Gastrointestinal obstruction symptoms or signs within 6 months before treatment start, unless fully resolved by surgery
- Unstable third-space fluid accumulation within 2 weeks before enrollment
- Severe infection within 4 weeks before enrollment or unexplained fever over 38.5°C within 2 weeks
- Severe cardiovascular or cerebrovascular disease within 6 months, including recent myocardial infarction, unstable angina, heart failure NYHA class II or above, significant arrhythmias
- Known or suspected interstitial lung disease with clinical symptoms
- History of neurological or psychiatric disorders like epilepsy or dementia
- Presence of severe or unhealed wounds or fractures
- Unrecovered adverse events from prior cancer therapy to grade 1, except alopecia and specified parameters
- History of other cancers within 5 years, except treated low-risk tumors
- Active hepatitis B or C, HIV, active syphilis, or active/recent tuberculosis
- Allergy to HRS-4642 components, Nimotuzumab, monoclonal antibodies, albumin-bound paclitaxel, or gemcitabine
- Any other condition that may affect study results or patient safety as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
2
the First Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Tingbo Liang, MD
CONTACT
Y
Yiwen Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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