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

NCT07176702 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-05

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-03-05
Completion
2027-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07176702 on ClinicalTrials.gov