The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation

An Open Label, Multicenter Phase Ib/II Clinical Study to Evaluate Efficacy , Safety and PK of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation

The purpose of this study was to assess efficacy, safety and PK in anaplastic thyroid cancer (ATC) given HLX208 (BRAF V600E inhibitor).

Inclusion Criteria:

1. Age>=18Y;
2. Good Organ Function;
3. Expected survival time ≥ 3 months;
4. Advanced BRAF V600 ATC that have been diagnosed histologically;
5. At least one measurable lesion as per RECIST v1.1;
6. ECOG score 0-1.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Previous treatment with BRAF inhibitors or MEK inhibitors;
3. A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin;
4. Severe active infections requiring systemic anti-infective therapy.