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Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1/2NCT06773130

HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma

A Phase 1/2 study testing HRS-4642 and Nimotuzumab in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by West China Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To evaluate the safety and efficacy of HRS-4642 combined with Nimotuzumab in patients with recurrent or metastatic pancreatic ductal adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Ductal Adenocarcinoma (PDAC)
What is being tested?
HRS-4642 and Nimotuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
10 Feb 2025to Mar 2027
Phase
Phase 1/2
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

  • Male and female subjects aged 18-75 years (including 18 and 75 years).
  • Pancreatic ductal adenocarcinoma confirmed by pathology (histology) or cytology.
  • Patients with metastatic pancreatic ductal adenocarcinoma.
  • At the time of study enrollment, according to the solid tumor efficacy evaluation criteria (RECIST1.1), imaging diagnosis had at least one measurable lesion (lesion diameter ≥10 mm and lymph node diameter ≥15 mm according to CT or MRI evaluation).
  • Physical condition score ECOG score 0-2 points.
  • Expected survival ≥ 12 weeks.
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  • Major organ function is normal.
  • The AE caused by previous anti-tumor therapy must be restored to the level of ≤ grade 1 (CTCAE v5.0) or the level specified in the inclusion criteria. If the investigator determines that NCI-CTCAE≤ grade 2 and there is no safety risk to the subject, the participant can be enrolled, such as receiving immune checkpoint inhibitor therapy. Subjects with type 1 diabetes and hypothyroidism that are stable after hormone replacement therapy.
  • Fertile female subjects must undergo a serum pregnancy test within 7 days before the first dose, and the result is negative; And must be non-lactating. Fertile female subjects and male subjects whose partners are women of reproductive age must agree to comply with the contraceptive requirement from the time of signing the informed consent until 30 days after the final administration of the trial drug (for subjects receiving HRS-4642);
  • The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.

Who cannot join

  • Patients will not be admitted to the study if they meet any of the following criteria:
  • The patient had previously used KRAS inhibitors or targeted EGFR therapy.
  • known allergy to the investigational drug or any of its components.
  • Systemic antitumor therapy (including unmarketed investigational drugs or therapies), such as chemotherapy, targeted therapy, and immunotherapy, has been received within 28 days prior to first administration, except for the following: oral fluorouracil and small-molecule targeted drugs within 14 days prior to first administration of investigational drugs or within 5 half-lives of drugs (whichever is longer). Chinese medicines with anti-tumor indications should be used within 14 days before the first use of the investigational drug; Surgical treatment (except diagnostic surgery) within 28 days prior to initial dosing; Patients who received local treatment such as radiotherapy, intervention or ablation within 14 days before the first dose.
  • Previous or concurrent suffering from other malignant tumors, Unless it is for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ, local prostate cancer, ductal carcinoma in situ of the breast after radical surgery, papillary carcinoma of the thyroid (allowing hormone therapy for non-metastatic prostate cancer or breast cancer) that has achieved complete remission at least 2 years prior to screening and does not require or is not expected to require other treatment during the study period;
  • accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history or current history of meningeal metastasis. Participants may be enrolled if their CNS metastases have been adequately localized (surgery or radiation) and do not require hormone therapy, and neurological recovery to baseline (except for lingering signs or symptoms associated with CNS treatment) is at least 2 weeks prior to initial treatment.
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  • Patients with severe cardiovascular and cerebrovascular thromboembolism (e.g., myocardial infarction, unstable angina pectoris, stroke), NYHA grade 2 or above cardiac dysfunction, and clinically significant supratrioventricular or ventricular arrhythmias requiring clinical intervention in the 6 months prior to study entry.
  • Study the presence of digestive tract obstruction or signs and symptoms of digestive tract obstruction within 6 months prior to the start of treatment, but screening can be performed if surgical treatment has been performed, and the obstruction has been completely resolved.
  • Bleeding events of esophageal and gastric varices caused by portal hypertension occurred within 3 months before the first administration.
  • Had undergone a gastroscopy within 3 months prior to the first dose indicating severe (G3) varicose veins that were untreated or did not recover after treatment; There is current portal hypertension (including imaging evidence of splenomegaly) and the investigator determined that admission to the study would cause a greater risk of bleeding.
  • Advanced patients who are symptomatic, have spread to the internal organs, and are at risk of developing life-threatening complications in the short term (including patients with uncontrolled large exudates [chest, pericardium, abdominal cavity]); If effusion drainage is performed, patients who have been stable for at least 2 weeks after drainage can be enrolled in the group (local treatment within the serous cavity is allowed according to the diagnosis and treatment routine before signing the information).
  • Known or suspected pulmonary disease such as interstitial lung disease, non-infectious pneumonia, COPD, pulmonary embolism or other serious and uncontrolled medical disease, acute infection, recent history of major surgery (within 28 days or have not recovered from side effects).
  • Patients who had active tuberculosis infection within 1 year before enrollment or had a history of active tuberculosis infection more than 1 year before but had not received formal treatment.
  • Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV surface antigen [HBsAg] test positive during screening and HBV-DNA test value ≥10000 copies /ml [2000 IU/ml]), Active hepatitis C (positive for HCV antibody [HCV-AB] and HCV RNA during screening) or co-infection with hepatitis B and hepatitis C.
  • Acute or chronic pancreatitis with significant clinical significance; Patients at high risk for pancreatitis, such as those with serum amylase and/or lipase concentrations ≥3 ULN.
  • Use of live attenuated vaccine within 28 days prior to the initial study administration, or anticipated use of live attenuated vaccine during the study treatment.
  • Participated in a clinical trial of any drug or medical device within 4 weeks prior to initial dosing.
  • The presence of uncontrollable mental illness and other circumstances known to affect the completion of the study procedure, such as alcohol, drug or substance abuse, and criminal detention.
  • Other situations that the researchers believe should not be included.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: An Exploratory Clinical Study of HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma

To evaluate the safety and efficacy of HRS-4642 combined with Nimotuzumab in patients with recurrent or metastatic pancreatic ductal adenocarcinoma.

Read the detailed description

This study is an open, single center, exploratory clinical trial aimed at evaluating the efficacy and safety of HRS-4642 combined with Nimotuzumab in the treatment of patients with recurrent or metastatic pancreatic ductal adenocarcinoma.

Being tested
HRS-4642, Nimotuzumab

What participants receive

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

  • HRS-4642Drug

    HRS-4642 will be administrated per dose level in which the patients are assigned.

  • NimotuzumabDrug

    400mg，ivgtt，d1，qw

Study groups in NCT06773130
Study groupRoleWhat they receive
HRS-4642+NimotuzumabExperimentalHRS-4642 in combination with Nimotuzumab, for recurrent or metastatic pancreatic ductal adenocarcinoma
Receives: Drug: HRS-4642; Drug: Nimotuzumab

What is being measured

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

  1. RP2D

    RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages.

    Measured: Approximately 12 months

  2. ORR

    ORR was evaluated by RECIST v1.1.

    Measured: Approximately 12 months

Secondary outcomes (5)

  1. DCR

    Disease control rate (DCR) is assessed by investigators using RECIST 1.1 criteria.

    Measured: 2 years

  2. DoR

    Duration of response (DoR) is assessed by investigators using RECIST 1.1 criteria.

    Measured: 2 years

  3. PFS

    Progression-free survival (PFS) is assessed by investigators using RECIST 1.1 criteria.

    Measured: 2 years

  4. OS

    Overall survival (OS) is assessed by investigators using RECIST 1.1 criteria.

    Measured: 2 years

  5. AEs

    AEs are assessed by NCI-CTCAE v5.0

    Measured: 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 posted14 Jan 2025
  2. Study start10 Feb 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionMar 2027 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06773130
Sponsor's protocol ID
PANC-2nd-IIT-HRS4642-NTZ
Status last verified
May 2026
First submitted
18 Dec 2024
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Leng Q, Zhou J, Wang X, Zhang P, Xu H, Cao D. HRS-4642 combined with nimotuzumab in the treatment of recurrent or metastatic pancreatic ductal adenocarcinoma: study protocol of a single-arm, prospective phase Ib/II trial. Front Pharmacol. 2025 Jul 4;16:1562481. doi: 10.3389/fphar.2025.1562481. eCollection 2025.

    PubMed 40689200

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HRS-4642 and Nimotuzumab in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by West China Hospital at 1 site 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 10 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D (time frame: Approximately 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06773130, which also lists 1 linked publication.

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 28 May 2026.

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