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

Anaplastic Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05102292
• Other study ID #: HLX208-ATC201
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: December 10, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anaplastic Thyroid Cancer
• Thyroid Carcinoma, Anaplastic
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• HLX208
HLX208 450mg bid po

Locations

Country	Name	City	State
China	Fudan University Affiliated Oncology Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)	up to 2 years
Secondary	PFS	Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )	from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Secondary	OS	Overall survival	from the date of first dose until the date of death from any cause,assessed up to 2 years