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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A:1L treatment | Experimental | HLX07 * 1000 mg+HLX10* 200mg +mFOLFOX6, IV, Q2W |
|
| B:≥2L treatment | Experimental | HLX07 *1000 mg monotherapy,IV, Q2W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX07 | Drug | 1000mg |
| |
| HLX10 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (assessed by investigator per RECIST V1.1) | up to 3 years |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall Survival | up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Junjie | Contact | : 86021-64175590 | junjiepeng67@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Peng Junjie | Fudan University Affiliated Oncology Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| C000722210 | HLX07 |
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| Drug |
200mg |
|
| mFOLFOX6 | Drug | OXA:85 mg/m2;LV:400 mg/m2;5-FU:400 mg/m2 |
|