The Efficacy and Safety of HLX208 in Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation

NCT ID: NCT05092815

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2024-10-30

Brief Summary

The purpose of this study was to assess safety, efficacy and PK in adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) given HLX208 (BRAF V600E inhibitor).

Conditions

Langerhans Cell Histiocytosis; Erdheim-Chester Disease; LCH; ECD

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. Volunteer to participate in the clinical study;

2. Aged ≥ 18 years;

3. Confirmed adult patients with LCH and/or ECD with BRAF V600E mutation;

4. At least one measurable lesion as per PERCIST v1.0;

5. Expected survival time ≥ 3 months;

6. ECOG score 0-2;

Exclusion Criteria

1. Previous treatment with BRAF inhibitors or MEK inhibitors;

2. A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery;

3. Severe active infections requiring systemic anti-infective therapy;

4. Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.

• 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

Peking Union Medical College Hospital

Beijing, , China

Countries

China

Other Identifiers

HLX208-LCH/ECD201

Identifier Type: -

Identifier Source: org_study_id