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Trial Title:
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Solid Tumor Patients With BRAF V600 Mutation
NCT ID:
NCT05528406
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HLX208
Description:
900mg bid po
Arm group label:
HLX208
Summary:
An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of
HLX208 (BRAF V600E Inhibitor) in Advanced Solid Tumor With BRAF V600 Mutation
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age>=18Y
- Good Organ Function
- Expected survival time ≥ 3 months
- advanced solid tumors with BRAF V600 mutation that have been diagnosed
- Previous failure to standard treatment, absence of standard treatment, or
insuitability for standard treatment at this stage.
- 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 6 months, has no evidence of progress on imagingwithin 4 weeks prior to initial
administration, and tumor-related clinical symptoms are stable)
- A history of other malignancies within two years, except for cured carcinoma in situ
of the cervix or basal cell carcinoma of the skin
- Patient with non-small cell lung cancer, anaplastic thyroid cancer, malignant
primary intracranial tumor, melanoma, colorectal cancer or hematological tumor（Vulva
and vaginal melanoma are excluded.）
- Severe active infections requiring systemic anti-infective therapy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 20, 2022
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Shanghai Henlius Biotech
Agency class:
Industry
Source:
Shanghai Henlius Biotech
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05528406
