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

ConditionCRC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Henlius Biotech

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age>=18Y and ≤75Y

Good Organ Function

Expected survival time ≥ 3 months

mCRC that have been diagnosed histologically

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • HLX07

    Drug

    1000mg

  • HLX10

    Drug

    200mg

  • mFOLFOX6

    Drug

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: A：1L treatmentExperimental treatment 3 interventions
Group B: B：≥2L treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

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

Time frame
up to 3 years
2

PFS

Progression-free survival (PFS) (assessed by the investigator per RECIST v1.1 )

Time frame
: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，up to 3 years

Secondary outcomes

1

OS

Overall Survival

Time frame
up to 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Henlius Biotech

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: