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

Henlius Pharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: CRC

Treatments: Drug: HLX07; Drug: HLX10; Drug: mFOLFOX6

Study type: Interventional

Funder types: Industry

Identifiers

NCT05239650

HLX07-mCRC201

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

A：1L treatment

Experimental group

Description:

HLX07 \* 1000 mg+HLX10\* 200mg +mFOLFOX6, IV, Q2W

Treatment:

Drug: HLX07

Drug: HLX10

Drug: mFOLFOX6

B：≥2L treatment

Experimental group

Description:

HLX07 \*1000 mg monotherapy,IV, Q2W

Treatment:

Drug: HLX07