Anaplastic Thyroid Cancer, ATC
Conditions
Brief summary
The purpose of this study was to assess efficacy, safety and PK in anaplastic thyroid cancer (ATC) given HLX208 (BRAF V600E inhibitor).
Interventions
DRUGHLX208
HLX208 450mg bid po
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 2 years | Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years | Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 ) |
| OS | from the date of first dose until the date of death from any cause，assessed up to 2 years | Overall survival |
Countries
China
Outcome results
None listed