- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05102292
The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation
August 16, 2023 updated by: Shanghai Henlius Biotech
An Open Label, Multicenter Phase Ib/II Clinical Study to Evaluate Efficacy , Safety and PK of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation
The purpose of this study was to assess efficacy, safety and PK in anaplastic thyroid cancer (ATC) given HLX208 (BRAF V600E inhibitor).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yu Wang
- Phone Number: 82700 86021-64175590
- Email: neck130@hotmail.com
Study Locations
-
-
-
Shanghai, China
- Fudan University Affiliated Oncology Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age>=18Y;
- Good Organ Function;
- Expected survival time ≥ 3 months;
- Advanced BRAF V600 ATC that have been diagnosed histologically;
- At least one measurable lesion as per RECIST v1.1;
- ECOG score 0-1.
Exclusion Criteria:
- Pregnant or lactating women;
- 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;
- Severe active infections requiring systemic anti-infective therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HLX208
Participants receive HLX208 450mg bid po
|
HLX208 450mg bid po
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: up to 2 years
|
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: from the date of first dose until the date of death from any cause,assessed up to 2 years
|
Overall survival
|
from the date of first dose until the date of death from any cause,assessed up to 2 years
|
PFS
Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
|
Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )
|
from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2021
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
October 20, 2021
First Submitted That Met QC Criteria
October 20, 2021
First Posted (Actual)
November 1, 2021
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 16, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HLX208-ATC201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anaplastic Thyroid Cancer
-
Saint Petersburg State University, RussiaWithdrawnThyroid Gland Anaplastic CarcinomaRussian Federation
-
Memorial Sloan Kettering Cancer CenterAstraZenecaCompletedMetastatic Anaplastic Thyroid CancerUnited States
-
University of Texas Southwestern Medical CenterNovartisWithdrawnMetastatic Anaplastic Thyroid Cancer | Locally Advanced Anaplastic, Undifferentiated Thyroid CancerUnited States
-
National Cancer Institute (NCI)NRG OncologyCompletedThyroid Gland Anaplastic CarcinomaUnited States
-
University of PennsylvaniaCompletedMetastatic Medullary Thyroid Cancer | Metastatic Differentiated Thyroid Cancer | Metastatic Anaplastic Thyroid Cancer | Metastatic Poorly Differentiated Thyroid CancerUnited States
-
Fujian Medical UniversityCompleted
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingThyroid Gland Anaplastic Carcinoma | BRAF V600K Mutation Present | BRAF NP_004324.2:p.V600EUnited States
-
Northwestern UniversityNational Cancer Institute (NCI)RecruitingLocally Advanced Thyroid Gland Anaplastic Carcinoma | Metastatic Thyroid Gland Anaplastic Carcinoma | Metastatic Thyroid Gland Oncocytic CarcinomaUnited States
-
M.D. Anderson Cancer CenterRecruitingThyroid Gland Anaplastic Carcinoma | Thyroid Gland Squamous Cell CarcinomaUnited States
-
Eisai Inc.TerminatedThyroid Carcinoma, AnaplasticItaly, United States, France, Australia, United Kingdom
Clinical Trials on HLX208
-
Shanghai Henlius BiotechNot yet recruiting
-
Shanghai Henlius BiotechRecruiting
-
Shanghai Henlius BiotechRecruiting
-
Shanghai Henlius BiotechRecruiting
-
Shanghai Henlius BiotechCompletedMass Balance Study in Healthy SubjectsChina
-
Shanghai Henlius BiotechActive, not recruitingLangerhans Cell Histiocytosis | Erdheim-Chester Disease | LCH | ECDChina
-
Shanghai Henlius BiotechActive, not recruitingMetastatic Colorectal Cancer | mCRCChina
-
Shanghai Henlius BiotechRecruitingNon Small Cell Lung CancerChina
-
Shanghai Henlius BiotechActive, not recruiting
-
Shanghai Henlius BiotechCompleted