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NCT Number: NCT05239650

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

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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Key information

Conditions

CRC

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HLX07

Drug

1000mg

HLX10

Drug

200mg

mFOLFOX6

Drug

OXA：85 mg/m2;LV:400 mg/m2；5-FU：400 mg/m2

Primary outcomes

  1. ORR

    Time frame: up to 3 years

    Objective response rate (assessed by investigator per RECIST V1.1)

  2. 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

  1. OS

    Time frame: up to 5 years

    Overall Survival

Study contacts

Contact information is provided by the study sponsor or research team.

Peng Junjie

CONTACT

[email protected]

: 86021-64175590

Sponsors and collaborators

Lead sponsor

Shanghai Henlius Biotech

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 15, 2022
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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