Status:
ACTIVE_NOT_RECRUITING
A Phase II Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Metastatic PDAC
HER2-positive Status
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 meta...
Eligibility Criteria
Inclusion
- 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
- 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 v5.0.
- 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.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07176702
Start Date
September 30 2025
End Date
September 1 2027
Last Update
December 5 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Nanjing Drum Tower Hospital
Nanjing, Nanjing, China, 210008
2
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200233