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

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

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 Overview

• Status: Not yet recruiting
• Conditions: CRC
• Intervention / Treatment: Drug: HLX07; Drug: HLX10; Drug: mFOLFOX6

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Peng Junjie; Phone Number: : 86021-64175590; Email: junjiepeng67@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A：1L treatment; HLX07 * 1000 mg+HLX10* 200mg +mFOLFOX6, IV, Q2W	Drug: HLX07; 1000mg; Drug: HLX10; 200mg; Drug: mFOLFOX6; OXA：85 mg/m2;LV:400 mg/m2；5-FU：400 mg/m2
Experimental: B：≥2L treatment; HLX07 *1000 mg monotherapy,IV, Q2W	Drug: HLX07; 1000mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall Survival	up to 5 years

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech
• Investigators: Principal Investigator: Peng Junjie, Fudan University Affiliated Oncology Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2022
• Primary Completion (Anticipated): October 15, 2025
• Study Completion (Anticipated): October 15, 2026

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 13, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HLX07-mCRC201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No