The Efficacy and Safety of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    25
  • sponsor
    Shanghai Henlius Biotech
Updated on 10 May 2022

Summary

The purpose of this study was to assess efficacy, safety and PK in metastatic colorectal cancer (mCRC) given HLX208 (BRAF V600E inhibitor).

Details
Condition Metastatic Colorectal Cancer, mCRC
Treatment HLX208
Clinical Study IdentifierNCT05127759
SponsorShanghai Henlius Biotech
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age>=18Y
Good Organ Function
Expected survival time ≥ 3 months
Metastatic/recurrent advanced BRAF V600E mCRC that have been diagnosed histologically and have failed first line treatment
At least one measurable lesion as per RECIST v1.1
ECOG score 0-1

Exclusion Criteria

Previous treatment with BRAF inhibitors or MEK inhibitors
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)
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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