HLX208 (BRAF V600E Inhibitor) in Combination With Trimetinib in Patients With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    220
  • sponsor
    Shanghai Henlius Biotech
Updated on 24 March 2022

Summary

A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trimetinib in patients with advanced solid tumors

Details
Condition Solid Tumor
Treatment HLX 208
Clinical Study IdentifierNCT04965220
SponsorShanghai Henlius Biotech
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Y≤Age≤75Y
Good Organ Function
Expected survival time ≥ 3 months
Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment
Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage
ECOG score 0-1
Expected survival time of more than 3 months

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)
Current or former patients with interstitial lung disease
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
Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period
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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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