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

Shanghai Henlius Biotech25 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Langerhans Cell Histiocytosis Erdheim-Chester Disease LCH ECD

Interventions

HLX208DRUG

HLX208 450mg bid po

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, China

Outcomes

Primary Outcomes

ORR

Objective response rate(assessed by independent review committee (IRC) based on the PERCIST Version 1.0)

Time frame: up to 1 year

Secondary Outcomes

AEs

Incidence and severity of adverse events

Time frame: up to 1 year

ORR

Objective response rate(assessed by the investigator based on the PERCIST v1.0)

Time frame: up to 1 year

ORR

Objective response rate(assessed by IRC and the investigator based on the RECIST v1.1)

Time frame: up to 1 year

DCR

Disease control rate (assessed by IRC and the investigator as per PERCIST v1.0 and RECIST v1.1 )

Time frame: up to 1 year

TTR

Time to response(assessed by IRC and the investigator as per PERCIST v1.0 and RECIST v1.1)

Time frame: up to 1 year

PFS

Progression-free survival (PFS) (assessed by IRC and the investigator as per PERCIST v1.0 and RECIST v1.1 )

Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 1 year

Overall survival

Time frame: from the date of first dose until the date of death from any cause，assessed up to 1 year

Data from ClinicalTrials.gov

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