The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment

  • STATUS
    Recruiting
  • End date
    Aug 15, 2023
  • participants needed
    50
  • sponsor
    Shanghai Henlius Biotech
Updated on 24 March 2022

Summary

An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment

Details
Condition CRC
Treatment Cetuximab Injection [Erbitux], HLX208
Clinical Study IdentifierNCT04984369
SponsorShanghai Henlius Biotech
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age>=18Y
Good Organ Function
Expected survival time ≥ 3 months
Metastatic/recurrent advanced BRAF+ mCRC that have been diagnosed histologically and have failed first line treatment
ECOG score 0-1

Exclusion Criteria

arm 1 : Previous treatment with BRAF inhibitors or MEK inhibitors
Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 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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