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

Henlius Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: ATC; Anaplastic Thyroid Cancer

Treatments: Drug: HLX208

Study type: Interventional

Funder types: Industry

Identifiers

NCT05102292

HLX208-ATC201

Details and patient eligibility

About

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

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

HLX208

Experimental group

Description:

Participants receive HLX208 450mg bid po

Treatment:

Drug: HLX208