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
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Shanghai Henlius Biotech
- Enrollment
- 50
- Primary Endpoint
- ORR
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
A：1L treatment
HLX07 * 1000 mg+HLX10* 200mg +mFOLFOX6, IV, Q2W
Intervention: HLX07 (Drug)
A：1L treatment
HLX07 * 1000 mg+HLX10* 200mg +mFOLFOX6, IV, Q2W
Intervention: HLX10 (Drug)
A：1L treatment
HLX07 * 1000 mg+HLX10* 200mg +mFOLFOX6, IV, Q2W
Intervention: mFOLFOX6 (Drug)
B：≥2L treatment
HLX07 *1000 mg monotherapy,IV, Q2W
Intervention: HLX07 (Drug)
Outcomes
Primary Outcomes
ORR
Time Frame: up to 3 years
Objective response rate (assessed by investigator per RECIST V1.1)
PFS
Time Frame: : 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 Outcomes
- OS(up to 5 years)