drugset / Trial / NCT07176702
A Phase II Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy
Phase 2
Active not recruiting
45 enrolled
Shanghai Zhongshan Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-09-30
- Primary completion
- 2027-03-05
- Completion
- 2027-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HLX22 | Monoclonal antibody | 15 mg/kg | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | — |