drugset / Trial / NCT05652894
A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer
RandomizedParallel-groupSingle-blindTreatment
Summary
The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), achieved by HX008 or Investigator's Choice Chemotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC).
Timeline
- Start
- 2023-02-28
- Primary completion
- 2026-06-30
- Completion
- 2028-10-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Comparator | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Comparator | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Comparator | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Comparator | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Comparator | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Pucotenlimab | Monoclonal antibody | 200 mg | Intravenous |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |