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

Phase 1

Active, not recruiting

• Conditions: Anaplastic Thyroid Cancer; ATC
• Interventions: Drug: HLX208

• Registration Number: NCT05102292
• Lead Sponsor: Shanghai Henlius Biotech

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-11-01
• Study Start: 2021-12-10
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HLX208	HLX208	Participants receive HLX208 450mg bid po

Primary Outcome Measures

Name	Time	Method
ORR	up to 2 years	Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fudan University Affiliated Oncology Hospital; 🇨🇳 Shanghai, China