Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC
- Registration Number
- NCT05239650
- Lead Sponsor
- Shanghai Henlius Biotech
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description B：≥2L treatment HLX07 HLX07 \*1000 mg monotherapy,IV, Q2W A：1L treatment HLX07 HLX07 \* 1000 mg+HLX10\* 200mg +mFOLFOX6, IV, Q2W A：1L treatment HLX10 HLX07 \* 1000 mg+HLX10\* 200mg +mFOLFOX6, IV, Q2W A：1L treatment mFOLFOX6 HLX07 \* 1000 mg+HLX10\* 200mg +mFOLFOX6, IV, Q2W
- Primary Outcome Measures
Name Time Method ORR up to 3 years Objective response rate (assessed by investigator per RECIST V1.1)
PFS : from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，up to 3 years Progression-free survival (PFS) (assessed by the investigator per RECIST v1.1 )
- Secondary Outcome Measures
Name Time Method OS up to 5 years Overall Survival