Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC
NCT ID: NCT05239650
Last Updated: 2022-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2022-07-15
2026-10-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A：1L treatment
HLX07 \* 1000 mg+HLX10\* 200mg +mFOLFOX6, IV, Q2W
HLX07
1000mg
HLX10
200mg
mFOLFOX6
OXA：85 mg/m2;LV:400 mg/m2；5-FU：400 mg/m2
B：≥2L treatment
HLX07 \*1000 mg monotherapy,IV, Q2W
HLX07
1000mg
Interventions
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HLX07
1000mg
HLX10
200mg
mFOLFOX6
OXA：85 mg/m2;LV:400 mg/m2；5-FU：400 mg/m2
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Henlius Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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Peng Junjie
Role: PRINCIPAL_INVESTIGATOR
Fudan University Affiliated Oncology Hospital
Central Contacts
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Other Identifiers
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HLX07-mCRC201
Identifier Type: -
Identifier Source: org_study_id
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