NCT05092815

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

December 6, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

2.6 years

First QC Date

September 24, 2021

Last Update Submit

August 7, 2023

Conditions

Langerhans Cell HistiocytosisErdheim-Chester DiseaseLCHECD

Outcome Measures

Primary Outcomes (1)

  • ORR

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

    up to 1 year

Secondary Outcomes (10)

  • AEs

    up to 1 year

  • ORR

    up to 1 year

  • ORR

    up to 1 year

  • DCR

    up to 1 year

  • TTR

    up to 1 year

  • +5 more secondary outcomes

Study Arms (1)

HLX208

EXPERIMENTAL

Participants receive HLX208 450mg bid po

Drug: HLX208

Interventions

HLX208DRUG

HLX208 450mg bid po

Also known as: BRAF V600E inhibitor
HLX208

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer to participate in the clinical study;
  • Aged ≥ 18 years;
  • Confirmed adult patients with LCH and/or ECD with BRAF V600E mutation;
  • At least one measurable lesion as per PERCIST v1.0;
  • Expected survival time ≥ 3 months;
  • ECOG score 0-2;

You may not qualify if:

  • Previous treatment with BRAF inhibitors or MEK inhibitors;
  • 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;
  • Severe active infections requiring systemic anti-infective therapy;
  • Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Histiocytosis, Langerhans-CellErdheim-Chester Disease

Interventions

CCT239065

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesHistiocytosisLymphatic DiseasesHemic and Lymphatic DiseasesHistiocytosis, Non-Langerhans-Cell

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2021

First Posted

October 26, 2021

Study Start

December 6, 2021

Primary Completion

June 30, 2024

Study Completion

October 30, 2024

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)