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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation

Phase II Study of HRS-4642 in Combination With Nimotuzumab and Chemotherapy for Subjects With Borderline Resectable Pancreatic Cancer With KRAS G12D Mutation

HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation (NCT07240766) is a Phase 2 interventional studying Borderline Resectable Pancreatic Adenocarcinoma, sponsored by Zhejiang University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Borderline Resectable Pancreatic Adenocarcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - your organs (liver, kidneys, etc.) are working well enough based on blood tests meeting the following requirements (no use of any blood components or colony-stimulating factors within 2 weeks prior to enrollment): 1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L 2. platelet count at least 80 × 10⁹/L 3. blood count (hemoglobin) at least 100 g/L 4. Serum albumin ≥ 30 g/L 5. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN and ALP ≤ 2.5 × ULN 6. kidney function (creatinine clearance) at least 50 mL/min or Serum creatinine ≤ 1.5 × ULN (Calculation formula see section 13.3) 7. Electrocardiogram: QTcF ≤ 450 ms (male), QTcF ≤ 470 ms (female) 8. 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 the end of treatment. For men, they must be surgically sterile or agree to use adequate contraception during the study and for 6 months after the end of treatment. - Voluntary participation in this study and signing of willing to sign a consent form, good compliance, and agreement to cooperate with follow-up. Who Should NOT Join This Trial: - 1\. Prior Treatment: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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): 1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L 2. Platelets ≥ 80 × 10⁹/L 3. Hemoglobin ≥ 100 g/L 4. Serum albumin ≥ 30 g/L 5. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN and ALP ≤ 2.5 × ULN 6. Creatinine clearance ≥ 50 mL/min or Serum creatinine ≤ 1.5 × ULN (Calculation formula see section 13.3) 7. Electrocardiogram: QTcF ≤ 450 ms (male), QTcF ≤ 470 ms (female) 8. 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 the end of treatment. For men, they must be surgically sterile or agree to use adequate contraception during the study and for 6 months after the end of treatment. * Voluntary participation in this study and signing of informed consent, good compliance, and agreement to cooperate with follow-up. Exclusion Criteria: * 1\. Prior Treatment: 1. Major surgical procedure or significant traumatic injury within 4 weeks prior to enrollment, or palliative local therapy (including but not limited to palliative radiotherapy, interventional therapy) within 2 weeks prior to enrollment. 2. Treatment with any investigational drug from another clinical study within 4 weeks prior to enrollment, except for participation in an observational (non-interventional) clinical study or the follow-up phase of an interventional study. 3. 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. Subjects may be screened if they have undergone surgical procedure resulting in complete resolution of the obstruction. * 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. Subjects with only small amounts of fluid visible on imaging and without clinical symptoms may be enrolled. * 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 (subjects with fever judged by the investigator to be due to the tumor may be enrolled); Presence of signs/symptoms of infection requiring intravenous antibiotic therapy within 2 weeks prior to enrollment (excluding prophylactic antibiotic use). * 6\. Severe cardiovascular and cerebrovascular diseases: 1. 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 thrombosis not requiring anticoagulation), and pulmonary embolism. 2. Poorly controlled cardiac symptoms or diseases, such as: 1. Myocardial infarction within 6 months. 2. Unstable angina. 3. Heart failure of NYHA class II or above. 4. Subjects 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 not affecting study drug administration). * 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 cancer, etc. * 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 antibody positive and HCV-RNA above the lower limit of detection of the assay). Known history of acquired immunodeficiency syndrome or positive HIV test. Active syphilis infection. Active tuberculosis or history of active tuberculosis infection within 48 weeks prior to screening, regardless of treatment. * 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 (including psychiatric disorders) requiring treatment, severely abnormal laboratory test values, family or social factors, and other circumstances that may affect patient safety or reliability of data collection.

Treatments Being Tested

DRUG

HRS-4642+AG+Nimotuzumab

HRS-4642 Injection: 500 mg intravenous infusion on Day 1, and 1200 mg intravenous infusion on Day 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. Nimotuzumab: 400 mg on Days 1 and 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. Paclitaxel for Injection (Albumin-bound): 125 mg/m² on Days 1 and 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. Gemcitabine: 1000 mg/m² on Days 1 and 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. The recommended adjuvant treatment regimen is to continue HRS-4642 + Nimotuzumab + AG for 4 cycles.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang, China
the First Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07240766), the sponsor (Zhejiang University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07240766 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07240766?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07240766?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07240766. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07240766. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.