Metastatic PDACPhase 2NCT07176702
A Phase II Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy
A Phase 2 study testing HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy in people with Metastatic PDAC and HER2-positive Status, run by Shanghai Zhongshan Hospital at 2 sites in China.
Trial summary
Pancreatic cancer is an extremely high-mortality malignancy. The chemotherapy regimen of gemcitabine combined with nab-paclitaxel (GEM-NABP) serves as one of the first-line standard therapies for metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic PDAC, HER2-positive Status
- What is being tested?
- HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesChina
- Study dates
- 30 Sep 2025to 1 Sep 2027
- 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
- Voluntary Participation Willingly participate in the clinical study; fully comprehend the study details and sign the Informed Consent Form (ICF); commit to and demonstrate capacity to complete all trial procedures.
- Age and Gender Any gender; age ≥18 and ≤75 years at the time of ICF signing.
- Diagnosis Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
- Prior Therapy *No prior systemic antitumor therapy for metastatic PDAC.
- Exception: Patients who received one cycle of chemotherapy (nab-paclitaxel + gemcitabine) as initial treatment for newly diagnosed PDAC may enroll.
- Prior neoadjuvant/adjuvant therapy is permitted if completed >6 months before enrollment, and treatment-related adverse events (AEs) have recovered to NCI-CTCAE ≤ Grade 1 (alopecia excluded).
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- Measurable Disease At least one measurable lesion per RECIST v1.1, assessed by the investigator. Target lesions must not be exclusively bone metastases.
- HER2 Status *HER2-positive defined by ASCO/CAP gastric cancer HER2 testing guidelines: IHC 3+ (primary or metastatic lesion), or IHC 2+ with ISH/FISH-positive confirmation.
- Note: ≤15 patients with IHC 2+/FISH-positive status may enroll.
- Performance Status ECOG performance status 0 or 1 within 7 days prior to first dose.
- Life Expectancy Expected survival ≥3 months.
- Hepatitis B *HBsAg-negative and HBcAb-negative. *If HBsAg-positive or HBcAb-positive, HBV-DNA must be <2500 copies/mL or 500 IU/mL (or within institutional normal range).
- Hepatitis C *HCV antibody-negative.
- If HCV antibody-positive, HCV-RNA must be negative.
- Exclusion: Co-infection of HBV and HCV (HBsAg/HBcAb-positive and HCV antibody-positive).
- HIV Status HIV antibody-negative.
- Organ Function
- Adequate organ function within 14 days before first dose (without transfusion, albumin, thrombopoietin, or CSF support):
- Hematology: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelets ≥100 × 10⁹/L Hemoglobin ≥90 g/L
- Liver: Total bilirubin ≤1.5 × ULN AST/ALT ≤2.5 × ULN (≤5 × ULN if liver metastases present) Alkaline phosphatase ≤5.0 × ULN Albumin ≥25 g/L
- Renal: Creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
- Coagulation: INR ≤1.5 × ULN APTT ≤1.5 × ULN PT ≤1.5 × ULN
- Contraception
- Females of childbearing potential: Negative serum pregnancy test within 7 days before first dose.
- All participants: Use of ≥1 medically approved contraceptive method (e.g., IUD, oral contraceptives, barrier devices) during treatment and for ≥7 months after last dose.
Who cannot join
- Other Malignancies
- History of other malignancies within 2 years prior to first dose, except:
- Curatively treated localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate/cervix/breast/thyroid).
- Prior Anthracycline Exposure
- Cumulative doxorubicin dose > 360 mg/m² (or equivalent):
- Equivalent agents: Epirubicin >720 mg/m², mitoxantrone >120 mg/m², idarubicin >90 mg/m², or liposomal doxorubicin >360 mg/m² doxorubicin-equivalent.
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- If multiple anthracyclines were used, the total cumulative dose must not exceed 360 mg/m² doxorubicin-equivalent.
- Prior HER2-Targeted Therapy Any previous HER2-targeted treatment (e.g., trastuzumab, pertuzumab).
- Active Gastrointestinal Bleeding
- ≥ Grade 2 toxicity per NCI-CTCAE v5.0.
- CNS Involvement Central nervous system (CNS) metastases and/or leptomeningeal metastases.
- Cardiovascular Events
- History within 6 months prior to first dose:
- Cerebrovascular accident, myocardial infarction, unstable angina, or poorly controlled arrhythmias.
- QTc interval ≥450 ms (males) or ≥470 ms (females) (Fridericia formula).
- Cardiac Dysfunction NYHA Class III-IV heart failure or left ventricular ejection fraction (LVEF) < 55% by echocardiography.
- Pulmonary/Infectious Conditions Interstitial lung disease (current or history). Active infection requiring systemic therapy or active tuberculosis.
- Recent Live Vaccines Administration of live attenuated vaccines within 28 days prior to first dose (exception: inactivated influenza or COVID-19 vaccines).
- Major Surgery Within 28 days prior to first dose.
- Radiotherapy Curative radiotherapy within 28 days prior to first dose.
- Concurrent Clinical Trials Current participation in other interventional studies or use of investigational drugs/devices within 28 days prior to first dose.
- Hypersensitivity Known severe allergy to monoclonal antibodies or excipients of the study drugs.
- Substance Abuse History of illicit drug use or psychiatric medication abuse.
- Pregnancy/Lactation Pregnant or breastfeeding women.
- Other Exclusionary Factors
- Any condition deemed by the investigator to:
- Compromise patient safety or data integrity. Require concomitant treatment for severe comorbidities (including psychiatric disorders).
- Exhibit critically abnormal laboratory values. Pose significant social/familial impediments to study completion.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Nanjing Drum Tower Hospital
Nanjing, Nanjing, 210008
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200233
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy for the First-Line Treatment of HER2-Positive Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is an extremely high-mortality malignancy. The chemotherapy regimen of gemcitabine combined with nab-paclitaxel (GEM-NABP) serves as one of the first-line standard therapies for metastatic pancreatic cancer. Given that traditional dual HER2 blockade (pertuzumab + trastuzumab) has demonstrated preliminary efficacy in HER2-expressing solid tumors, the novel clinical strategy of dual HER2 blockade (HLX22 + trastuzumab) combined with GEM-NAP offers the potential to improve outcomes for patients with HER2-positive pancreatic cancer.
- Conditions
- Metastatic PDAC, HER2-positive Status
- Being tested
- HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy
- Medical subject headings
- Anophthalmia with pulmonary hypoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and ChemotherapyDrug
Drugs: HLX22 (15 mg/kg IV) + trastuzumab (8 mg/kg loading dose → 6 mg/kg maintenance) + nab-paclitaxel (125 mg/m² IV) + gemcitabine (1000 mg/m² IV).
Administration: Administered every 3 weeks until disease progression, unacceptable toxicity, or withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| HLX22 in Combination with Trastuzumab and Chemotherapy | Experimental | Not described Receives: Drug: HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) assessed by investigators per RECIST v1.1.
Measured: up to 36 months
Secondary outcomes (5)
Progression-Free Survival (PFS)
Measured: up to 12 months
Overall Survival (OS)
Measured: up to 36 months
Disease Control Rate (DCR)
Measured: up to 36months
Duration of Response (DOR)
Measured: up to 36 months
Incidence of Adverse Events (AEs)
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start30 Sep 2025
- Primary completion5 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic PDACStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Liu, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176702
- Sponsor's protocol ID
- HLX22-IIT-PDAC201
- Status last verified
- Nov 2025
- First submitted
- 26 Aug 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy for the First-Line Treatment of HER2-Positive Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07176702
- Acronym / sponsor ID
- HLX22-IIT-PDAC201
- Conditions
- Metastatic PDAC, HER2-positive Status
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 5 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic cancer is an extremely high-mortality malignancy. The chemotherapy regimen of gemcitabine combined with nab-paclitaxel (GEM-NABP) serves as one of the first-line standard therapies for metastatic pancreatic cancer. Given that traditional dual HER2 blockade (pertuzumab + trastuzumab) has demonstrated preliminary efficacy in HER2-expressing solid tumors, the novel clinical strategy of dual HER2 blockade (HLX22 + trastuzumab) combined with GEM-NAP offers the potential to improve outcomes for patients with HER2-positive pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLX22 in Combination with Trastuzumab and Chemotherapy | Experimental | Drug: HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Voluntary Participation Willingly participate in the clinical study; fully comprehend the study details and sign the Informed Consent Form (ICF); commit to and demonstrate capacity to complete all trial procedures.
- Age and Gender Any gender; age ≥18 and ≤75 years at the time of ICF signing.
- Diagnosis Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
- Prior Therapy *No prior systemic antitumor therapy for metastatic PDAC.
- Exception: Patients who received one cycle of chemotherapy (nab-paclitaxel + gemcitabine) as initial treatment for newly diagnosed PDAC may enroll.
Key exclusion criteria (28 listed)
- Other Malignancies
- Curatively treated localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate/cervix/breast/thyroid).
- Prior Anthracycline Exposure
- Equivalent agents: Epirubicin >720 mg/m², mitoxantrone >120 mg/m², idarubicin >90 mg/m², or liposomal doxorubicin >360 mg/m² doxorubicin-equivalent.
- If multiple anthracyclines were used, the total cumulative dose must not exceed 360 mg/m² doxorubicin-equivalent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and ChemotherapyDrugs: HLX22 (15 mg/kg IV) + trastuzumab (8 mg/kg loading dose → 6 mg/kg maintenance) + nab-paclitaxel (125 mg/m² IV) + gemcitabine (1000 mg/m² IV). Administration: Administered every 3 weeks until disease progression, unacceptable toxicity, or withdrawal. | Drug | HLX22 in Combination with Trastuzumab and Chemotherapy |
Primary outcome
Objective Response Rate (ORR) assessed by investigators per RECIST v1.1.
Time frame: up to 36 months
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: up to 12 months
Overall Survival (OS)
Time frame: up to 36 months
Disease Control Rate (DCR)
Time frame: up to 36months
Duration of Response (DOR)
Time frame: up to 36 months
Incidence of Adverse Events (AEs)
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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RecruitingPhase 3
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RecruitingPhase 2
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy in people with Metastatic PDAC and HER2-positive Status, run by Shanghai Zhongshan Hospital 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 25 inclusion and 28 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 5 Dec 2025. 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?
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?
Objective Response Rate (ORR) assessed by investigators per RECIST v1.1. (time frame: up to 36 months). 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 5 Dec 2025.