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

• Status: Not yet recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Henlius Biotech

Criteria

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.