A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation

  • STATUS
    Recruiting
  • End date
    Aug 30, 2024
  • participants needed
    30
  • sponsor
    Shanghai Henlius Biotech
Updated on 12 May 2022

Summary

An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation

Details
Condition Advanced Melanoma
Treatment HLX208
Clinical Study IdentifierNCT05114603
SponsorShanghai Henlius Biotech
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age>=18Y
Good Organ Function
Expected survival time ≥ 3 months
advanced melanoma with BRAF V600 mutation that have been diagnosed
ECOG score 0-1

Exclusion Criteria

Previous treatment with BRAF inhibitors or MEK inhibitors
Symptomatic brain or meningeal metastases (unless the patient has beenon > treatment for 3 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinicalsymptoms are stable)
Severe active infections requiring systemic anti-infective therapy
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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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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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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