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NCT05239650 Clinical Trial

Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC

CRC Clinical Trial

Official title:
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05239650
Other study ID # HLX07-mCRC201
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date July 15, 2022
Est. completion date October 15, 2026

Study information
Verified date February 2022
Source Shanghai Henlius Biotech
Contact Peng Junjie
Phone : 86021-64175590
Email junjiepeng67@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date October 15, 2026
Est. primary completion date October 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Age>=18Y and =75Y - Good Organ Function - Expected survival time = 3 months - mCRC that have been diagnosed histologically - KRAS/NRAS/BRAF WT verified by PCR or NGS of tumor tissue - ECOG score 0-1; Exclusion Criteria: - HIV infection - Active clinical severe infection; - A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• HLX07
1000mg
• HLX10
200mg
• mFOLFOX6
OXA:85 mg/m2;LV:400 mg/m2;5-FU:400 mg/m2

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Henlius Biotech

Outcome
Type Measure Description Time frame Safety issue
Primary ORR Objective response rate (assessed by investigator per RECIST V1.1) up to 3 years
Primary PFS Progression-free survival (PFS) (assessed by the investigator per RECIST v1.1 ) : from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),up to 3 years
Secondary OS Overall Survival up to 5 years
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