Clinical trial · Interventional
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
NCT05102292CI-TRIAL-00068924unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to assess efficacy, safety and PK in anaplastic thyroid cancer (ATC) given HLX208 (BRAF V600E inhibitor).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Thyroid Cancer | Thyroid Gland Anaplastic Carcinoma | ALIAS | 0.90 |
| ATC | Thyroid Gland Anaplastic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HLX208 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HLX208
- description
- Participants receive HLX208 450mg bid po
- interventionNames
- Drug: HLX208
Primary outcomes (1)
- measure
- ORR
- timeFrame
- up to 2 years
- description
- Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
Secondary outcomes (2)
- measure
- PFS
- timeFrame
- from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.