NCT07176702Active, not recruitingPhase 2
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
Shanghai Zhongshan Hospital2 sites in 1 country45 target enrollmentStarted: September 30, 2025Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Objective Response Rate (ORR) assessed by investigators per RECIST v1.1.
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
- •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.
Exclusion Criteria
- •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.
- •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.
- •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.
Arms & Interventions
HLX22 in Combination with Trastuzumab and Chemotherapy
Experimental
Intervention: HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy (Drug)
Outcomes
Primary Outcomes
Objective Response Rate (ORR) assessed by investigators per RECIST v1.1.
Time Frame: up to 36 months
Secondary Outcomes
- Progression-Free Survival (PFS)(up to 12 months)
- Overall Survival (OS)(up to 36 months)
- Disease Control Rate (DCR)(up to 36months)
- Duration of Response (DOR)(up to 36 months)
- Incidence of Adverse Events (AEs)(up to 36 months)
Investigators
Liang Liu
Professor & Chief Physician
Shanghai Zhongshan Hospital
Study Sites (2)
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