NCT05652894

A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer

A Randomized Phase III Study of HX008 (a Humanized Monoclonal Antibody Against PD-1) Compared to Investigator's Choice Chemotherapy in the First-Line Treatment of Subjects With Microsatellite Instability-High (MSI-H)/Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Taizhou Hanzhong biomedical co. LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	HX008	Drug: HX008 200 mg ,Q3W
DRUG	Investigator's Choice Chemotherapy	Drug: bevacizumab 5mg/kg given by IV every 14 days. Other Name: Avastin Drug: cetuximab 400 mg/sqm initial dose, then 250 mg/sqm once weekly thereafter. Other Name: Erbitux Drug: oxaliplatin 8 5 mg/sqm by IV, day1. Component of mFOLFOX6. Drug: irinotecan 180 mg/sqm by IV, day1.Component of FOLFORI. Drug: calcium Folinate 400 mg/sqm by IV, day1.Component of mFOLFOX6 or FOLFORI. Drug: 5-fluorouracil 400 mg/sqm, day1,followed by 2400 mg/sqm iv infusion over 46\~48 h.Component of mFOLFOX6 or FOLFORI.

Timeline

• Start date: 2022-12-20
• Primary completion: 2026-01-19
• Completion: 2028-10-20
• First posted: 2022-12-15
• Last updated: 2022-12-15

Locations

10 sites across 1 country: China