The Efficacy and Safety of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation
NCT ID: NCT05127759
Last Updated: 2023-08-08
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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UNKNOWN
PHASE2
25 participants
INTERVENTIONAL
2022-03-23
2025-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HLX208
Participants receive HLX208 450mg bid po
HLX208
HLX208 450mg bid po
Interventions
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HLX208
HLX208 450mg bid po
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Good Organ Function;
3. Expected survival time ≥ 3 months;
4. Metastatic/recurrent advanced BRAF V600E mCRC that have been diagnosed histologically and have failed first line treatment;
5. At least one measurable lesion as per RECIST v1.1;
6. ECOG score 0-1.
Exclusion Criteria
2. Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
3. Active clinical severe infection;
4. 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
ALL
No
Sponsors
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Shanghai Henlius Biotech
INDUSTRY
Responsible Party
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Locations
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Liaoning Cancer Hospital
Shenyang, Liaoning, China
Countries
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Other Identifiers
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HLX208-mCRC202
Identifier Type: -
Identifier Source: org_study_id
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