Trial Radar AI | ||
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Clinical Trial NCT07176702 for Metastatic PDAC, HER2-positive Status is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
A Phase II Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy Phase 2 45 Novel Treatment
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
- HLX22-IIT-PDAC201
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalHLX22 in Combination with Trastuzumab and Chemotherapy | HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy 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. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective Response Rate (ORR) assessed by investigators per RECIST v1.1. | up to 36 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
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.
- 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.
Shanghai Zhongshan HospitalThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolNanjing
Shanghai Municipality