A Phase II Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy

NCT07176702 | Active Not Recruiting Phase 2

• 1 other identifier: HLX22-IIT-PDAC201
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Metastatic PDAC; HER2-positive Status

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) assessed by investigators per RECIST v1.1.

  up to 36 months

Secondary Outcomes (5)

• 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

Study Arms (1)

HLX22 in Combination with Trastuzumab and Chemotherapy

EXPERIMENTAL

Drug: HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy

Interventions

HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy DRUG

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.

HLX22 in Combination with Trastuzumab and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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):

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Shanghai Zhongshan Hospital: lead

Study Sites (2)

Nanjing Drum Tower Hospital

Nanjing, Nanjing, 210008, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Anophthalmia with pulmonary hypoplasia

Interventions

Trastuzumab; Drug Therapy

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chief Physician

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 16, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CN (2)