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

NCT ID: NCT05102292

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-10
• Study Completion Date: 2024-12-30

Brief Summary

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

Conditions

Anaplastic Thyroid Cancer; ATC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HLX208

Participants receive HLX208 450mg bid po

Group Type: EXPERIMENTAL

HLX208

Intervention Type: DRUG

HLX208 450mg bid po

Interventions

HLX208

HLX208 450mg bid po

Intervention Type: DRUG

Other Intervention Names

BRAF V600E inhibitor

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Affiliated Oncology Hospital

Shanghai, , China

Countries

China

Other Identifiers

HLX208-ATC201

Identifier Type: -

Identifier Source: org_study_id