Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT07176702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537768', 'term': 'Anophthalmia with pulmonary hypoplasia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) assessed by investigators per RECIST v1.1.', 'timeFrame': 'up to 36 months'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'up to 12 months'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'up to 36 months'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'up to 36months'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'up to 36 months'}, {'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'up to 36 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic PDAC', 'HER2-positive Status']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Age and Gender Any gender; age ≥18 and ≤75 years at the time of ICF signing.\n* Diagnosis Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).\n* Prior Therapy \\*No prior systemic antitumor therapy for metastatic PDAC.\n\n \\*Exception: Patients who received one cycle of chemotherapy (nab-paclitaxel + gemcitabine) as initial treatment for newly diagnosed PDAC may enroll.\n\n \\*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).\n* Measurable Disease At least one measurable lesion per RECIST v1.1, assessed by the investigator. Target lesions must not be exclusively bone metastases.\n* 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.\n\n \\*Note: ≤15 patients with IHC 2+/FISH-positive status may enroll.\n* Performance Status ECOG performance status 0 or 1 within 7 days prior to first dose.\n* Life Expectancy Expected survival ≥3 months.\n* 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).\n* Hepatitis C \\*HCV antibody-negative.\n\n * If HCV antibody-positive, HCV-RNA must be negative.\n * Exclusion: Co-infection of HBV and HCV (HBsAg/HBcAb-positive and HCV antibody-positive).\n* HIV Status HIV antibody-negative.\n* Organ Function\n\nAdequate organ function within 14 days before first dose (without transfusion, albumin, thrombopoietin, or CSF support):\n\n\\*Hematology: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelets ≥100 × 10⁹/L Hemoglobin ≥90 g/L\n\n\\*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\n\n\\*Renal: Creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)\n\n\\*Coagulation: INR ≤1.5 × ULN APTT ≤1.5 × ULN PT ≤1.5 × ULN\n\n* Contraception\n\n * Females of childbearing potential: Negative serum pregnancy test within 7 days before first dose.\n * 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.\n\nExclusion Criteria:\n\n* Other Malignancies\n\nHistory of other malignancies within 2 years prior to first dose, except:\n\nCuratively treated localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate/cervix/breast/thyroid).\n\n* Prior Anthracycline Exposure\n\nCumulative doxorubicin dose \\> 360 mg/m² (or equivalent):\n\nEquivalent agents: Epirubicin \\>720 mg/m², mitoxantrone \\>120 mg/m², idarubicin \\>90 mg/m², or liposomal doxorubicin \\>360 mg/m² doxorubicin-equivalent.\n\nIf multiple anthracyclines were used, the total cumulative dose must not exceed 360 mg/m² doxorubicin-equivalent.\n\n* Prior HER2-Targeted Therapy Any previous HER2-targeted treatment (e.g., trastuzumab, pertuzumab).\n* Active Gastrointestinal Bleeding\n\n ≥ Grade 2 toxicity per NCI-CTCAE v5.0.\n* CNS Involvement Central nervous system (CNS) metastases and/or leptomeningeal metastases.\n* Cardiovascular Events\n\nHistory within 6 months prior to first dose:\n\nCerebrovascular accident, myocardial infarction, unstable angina, or poorly controlled arrhythmias.\n\nQTc interval ≥450 ms (males) or ≥470 ms (females) (Fridericia formula).\n\n* Cardiac Dysfunction NYHA Class III-IV heart failure or left ventricular ejection fraction (LVEF) \\< 55% by echocardiography.\n* Pulmonary/Infectious Conditions Interstitial lung disease (current or history). Active infection requiring systemic therapy or active tuberculosis.\n* Recent Live Vaccines Administration of live attenuated vaccines within 28 days prior to first dose (exception: inactivated influenza or COVID-19 vaccines).\n* Major Surgery Within 28 days prior to first dose.\n* Radiotherapy Curative radiotherapy within 28 days prior to first dose.\n* Concurrent Clinical Trials Current participation in other interventional studies or use of investigational drugs/devices within 28 days prior to first dose.\n* Hypersensitivity Known severe allergy to monoclonal antibodies or excipients of the study drugs.\n* Substance Abuse History of illicit drug use or psychiatric medication abuse.\n* Pregnancy/Lactation Pregnant or breastfeeding women.\n* Other Exclusionary Factors\n\nAny condition deemed by the investigator to:\n\nCompromise patient safety or data integrity. Require concomitant treatment for severe comorbidities (including psychiatric disorders).\n\nExhibit critically abnormal laboratory values. Pose significant social/familial impediments to study completion.'}, 'identificationModule': {'nctId': 'NCT07176702', 'briefTitle': 'A Phase II Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HLX22-IIT-PDAC201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HLX22 in Combination with Trastuzumab and Chemotherapy', 'interventionNames': ['Drug: HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy']}], 'interventions': [{'name': 'HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy', 'type': 'DRUG', 'description': '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).\n\nAdministration: Administered every 3 weeks until disease progression, unacceptable toxicity, or withdrawal.', 'armGroupLabels': ['HLX22 in Combination with Trastuzumab and Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Nanjing', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200233', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor & Chief Physician', 'investigatorFullName': 'Liang Liu', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}