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Metastatic Pancreatic CarcinomaPhase 2NCT06770452

HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients

A Phase 2 study testing HRS-4642, Nimotuzumab and gemcitabine + nab-paclitaxel in people with Metastatic Pancreatic Carcinoma, run by Zhejiang University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a single-arm phase II clinical study to include 32 patients with advanced pancreatic cancer with KRAS G12D mutation to evaluate the effectiveness of HRS-4642 combined with nitutuzumab and AG for first-line treatment of advanced pancreatic cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Pancreatic Carcinoma
What is being tested?
HRS-4642, Nimotuzumab and gemcitabine + nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
2 sitesChina
Study dates
25 Mar 2025to 1 Feb 2028
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Age: 18-75 (including 18 and 75); 2.Metastatic pancreatic cancer (from pancreatic ductal epithelium) for Arm A; Locally advanced pancreatic cancer (from pancreatic ductal epithelium) for Arm B; 3.Tumor tissue contains KRAS G12D mutation; 4.No systemic antitumor therapy in advanced stage; if previous neoadjuvant / adjuvant therapy, last treatment should be over 6 months; 5.At least one measurable lesion according to the RECIST v1.1 criteria; 6.The ECOG (Eastern Cooperative Oncology) score was 0-1; 7.Expected survival period of 3 months; 8.The functions of vital organs meets the following requirements (any blood components, cell growth factors are not allowed 2 weeks prior to enrollment):
  • Neutrophil count≥1.5×10^9 / L;
  • Platelet≥100×10^9 / L;
  • Hemoglobin≥100 g / L;
  • Serum albumin≥30 g / L;
  • Total bilirubin≤1.5×ULN; ALT, AST≤3×ULN and ALP≤2.5×ULN; if the patient has liver metastasis, ALT, ALT and AST≤5×ULN; if the patient has liver or bone metastasis, ALP≤5×ULN;
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  • Creatinine clearance≥50 mL/min or serum creatinine ≤1.5×ULN;
  • Urinary protein <2+; if urine protein≥2+, an additional 24 hours urine protein quantification should be tested, and if 24 hours urine protein quantification <1g can be enrolled;
  • ECG: QTcF≤450 ms (male), QTcF≤470 ms (female);
  • Cardiac color ultrasound: LVEF (left ventricular ejection fraction) ≥50%; 9.Women of childbearing age must have a blood pregnancy test within 7 days before enrollment, the result should be negative and must be non-lactating and should be willing to use appropriate contraception during the trial and within 6 months of treatment. For men, surgical sterilization or consent to use appropriate contraception during the study and within 6 months after completion of treatment.
  • 10.Volunteer to participate in the study and sign the informed consent form, good compliance, agreed to cooperate with the follow-up.

Who cannot join

  • 1.Previous treatment:
  • Previous treatment of targeted therapy against KRAS G12D.
  • Previous targeted therapy against EGFR.
  • Received major surgery or major trauma within 4 weeks before enrollment, or palliative local treatment (including but not limited to palliative radiotherapy, interventional therapy) within 2 weeks prior to enrollment.
  • Have received any other clinical study medication within 4 weeks before enrollment, except for an observational (non-interventional) clinical study or interventional clinical study follow-up.
  • (5)14 days before enrollment with drugs that strongly inhibit or induce the hepatic drug-metabolizing enzymes CYP3A4 or CYP2C8.
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  • 2.The presence of a central nervous system (CNS) metastases. 3.Acute or chronic pancreatitis requiring clinical intervention. 4.Symptoms and signs of gastrointestinal obstruction or obstruction within 6 months before initiation of study treatment but can be screened if surgery is performed and the obstruction is completely resolved.
  • 5.Within 2 weeks prior to enrollment, there is a third space effusion (such as a large amount of pleural fluid, ascites, etc.) that can not reach the stable state (no intervention treatment is needed after the removal of the drainage tube), and only a small amount of effusion on imaging and without clinical symptoms can be enrolled.
  • 6.Severe infection occurred within 4 weeks before enrollment, such as severe pneumonia, bacteremia, infectious complications, requiring hospitalization; fever of unknown cause> 38.5℃ within 2 weeks before enrollment (fever caused by the tumor according to the investigator); 2 weeks of enrollment (except in cases of prophylactic antibiotics).
  • 7.Severe cardiovascular and cerebrovascular disease. 8.Patients with known or suspected interstitial pneumonia except only interstitial changes on imaging.
  • 9.Prior history of clear neurological or psychiatric disorders, including epilepsy and dementia.
  • 10.Presence of non-healing wounds (severe, non-healing or split), uncured fractures.
  • 11.Adverse events due to prior treatment prior to enrollment did not return to NCI-CTCAE level 1 (except for alopecia and enrollment criteria; except AEs not affecting the study medication).
  • 12.Malignant tumors other than the primary tumor within the 5 years before enrollment, except those with low risk of metastasis and death: adequately treated cervical carcinoma in situ, skin basal cells or squamous cell carcinoma, etc.
  • 13.Combined with active hepatitis B (hepatitis B surface antigen positive and HBV DNA 500 IU / mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection of the analytical method). Those known to have acquired immunodeficiency syndrome or test positive for HIV, and those infected with active syphilis. Subjects with active tuberculosis or a history of active tuberculosis infection within 48 weeks before screening, with or without treatment.
  • 14.Known to be allergic to any component of HRS-4642; allergic to any component of nytuzumab or other monoclonal antibody / fusion proteins, albumin paclitaxel, gemcitabine.
  • 15.By the investigator, the patient had other factors that might affect the study results or lead to the forced termination of the study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 2 recruiting
  • First Affiliated Hospital of Zhejiang University Schlool of Medicine

    Hangzhou, Zhejiang, 310000

    Yiwen Chen, MD, 86+15088682641, cherry0705@zju.edu.cn

    Not yet recruiting
  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Yiwen Chen, 86+19941463683, yiwenchen0705@126.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm Phase II Study of HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients With KRAS G12D Mutations

This study is a single-arm phase II clinical study to include 32 patients with advanced pancreatic cancer with KRAS G12D mutation to evaluate the effectiveness of HRS-4642 combined with nitutuzumab and AG for first-line treatment of advanced pancreatic cancer.

Read the detailed description

This study used a Simon two-stage design, with at least 15 subjects enrolled in the first stage. During this period, after 6-9 subjects complete the first cycle of treatment, the existing safety data shall be summarized and analyzed to integrate the safety results to assess the tolerance. If tolerated, the proposed dose, other dose level or dosage regimen shall be discussed by investigators. As with> 5 achieved remission (CR / PR), enrollment continued to 32; if 5 were remitted, the SMC assessed assessed and decided. The study process included screening, treatment and follow-up periods (safety and survival follow-up after termination of study treatment).

Being tested
HRS-4642, Nimotuzumab, gemcitabine + nab-paclitaxel
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRS-4642Drug

    HRS-4642 is a KRAS G12D inhibitor

  • NimotuzumabDrug

    Nimotuzumab is a humanized IgG 1 monoclonal antibody targeting EGFR

  • gemcitabine + nab-paclitaxelDrug

    Albumin paclitaxel 125mg/m2 intravenous infusion, gemcitabine 1000mg / m2, D1,8, a cycle every 3 weeks

Study groups in NCT06770452
Study groupRoleWhat they receive
Arm A-STAGE 1ExperimentalApproximately 10-15 subjects will be enrolled in the first stage. During this period, after obtaining the initial efficacy evaluation results from the first 10 subjects, the existing safety and efficacy data will be summarized and analyzed. Integrating safety and efficacy outcomes, the SMC will assess whether to proceed to the second stage at the planned dose, or to discuss and determine alternative dose levels or dosing regimens. Eligible patients will receive HRS-4642, combined with Nimotuzumab and AG regimen, predose regimen: HRS-4642 500mg intravenous infusion, D1,1200mg IV infusion, D8, every 3 weeks; Nimotuzumab 400mg intravenous infusion, D1,8, every 3 weeks; Albumin paclitaxel 125mg/m2 intravenous infusion, gemcitabine 1000mg / m2, D1,8, a cycle every 3 weeks until disease progression or toxicity intolerance.
Receives: Drug: HRS-4642; Drug: Nimotuzumab; Drug: gemcitabine + nab-paclitaxel
Arm A (STAGE 2: Cohort 1)ExperimentalThe second stage is a randomized, open-label study, with a planned enrollment of 39 subjects per group. Eligible subjects will be randomized in a 1:1 ratio, with stratification factors including history of radical surgery (yes vs. no). Eligible subjects will be randomized into Cohort 1 or Cohort 2 to receive corresponding treatments. In Cohort 1, subjects will receive HRS-4642 in combination with nimotuzumab and AG.
Receives: Drug: HRS-4642; Drug: Nimotuzumab; Drug: gemcitabine + nab-paclitaxel
Arm A (STAGE 2: Cohort 2)Active comparatorThe second stage is a randomized, open-label study, with a planned enrollment of 39 subjects per group. Eligible subjects will be randomized in a 1:1 ratio. Eligible subjects will be randomized into Cohort 1 or Cohort 2 to receive corresponding treatments. In cohort 2, subjects will receive HRS-4642 in combination with AG.
Receives: Drug: HRS-4642; Drug: gemcitabine + nab-paclitaxel
Arm B: Cohort 1ExperimentalCohort 1 will enroll 5-10 subjects with LAPC to evaluate the efficacy of HRS-4642 combined with AG and nimotuzumab as first-line treatment. Based on safety and efficacy data, a decision will be made on whether to continue enrollment in this cohort up to a maximum of 30 subjects.
Receives: Drug: HRS-4642; Drug: Nimotuzumab; Drug: gemcitabine + nab-paclitaxel
Arm B: cohort 2ExperimentalCohort 2 will enroll 5-10 subjects with LAPC to evaluate the efficacy of HRS-4642 combined with AG as first-line treatment.
Receives: Drug: HRS-4642; Drug: gemcitabine + nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective reponse rate (ORR)

    The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole study

    Measured: Up to 2 years

Secondary outcomes (4)
  1. Duration of remission (DoR)

    The time from the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause during the whole study.

    Measured: Up to 2 years

  2. Disease control rate (DCR)

    The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during the whole study.

    Measured: Up to 2 years

  3. Progression-free survival (PFS)

    The time from enrolled to disease pregression or death from any cause during the whole study.

    Measured: Up to 2 years

  4. Overall survival (OS)

    The time from enrolled to death from any cause during the whole study.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2025
  2. Study start25 Mar 2025
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cohort A plans to enroll 88-93 patients with advanced pancreatic cancer harboring the KRAS G12D mutation, divided into two stages. First Stage: Approximately 10-15 subjects will be enrolled in the first stage. Second Stage: The second stage is a randomized, open-label study, with a planned enrollment of 39 subjects per group. Eligible subjects will be randomized in a 1:1 ratio. Cohort B: Cohort 1 will enroll 5-10 subjects with LAPC to evaluate the efficacy of HRS-4642 combined with AG and nimotuzumab as first-line treatment. Based on safety and efficacy data, a decision will be made on whether to continue enrollment in this cohort up to a maximum of 30 subjects. Cohort 2 will enroll 5-10 subjects with LAPC to evaluate the efficacy of HRS-4642 combined with AG as first-line treatment.
Masking
None (open label)
Enrolment
133 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06770452
Sponsor's protocol ID
CAPT04
Status last verified
Sep 2025
First submitted
7 Jan 2025
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HRS-4642, Nimotuzumab and gemcitabine + nab-paclitaxel in people with Metastatic Pancreatic Carcinoma, run by Zhejiang University at 2 sites in China.

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 11 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Tingbo Liang, MD (86+19941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective reponse rate (ORR) (time frame: Up to 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 3 Jun 2026.

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