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Not yet recruiting NCT05239650

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

Phase II Interventional CRC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HLX07, HLX10, mFOLFOX6.
Who it may be relevant to
Registry conditions: CRC. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug HLX07
    1000mg
  • Drug HLX10
    200mg
  • Drug mFOLFOX6
    OXA：85 mg/m2;LV:400 mg/m2；5-FU：400 mg/m2

Primary outcome measures

  • ORR [Time frame: up to 3 years]
  • PFS [Time frame: : from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，up to 3 years]
Secondary outcome measures (1)
  • OS [Time frame: up to 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05239650 · HLX07-mCRC201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗