Back to resultsThe Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation
Primary Purpose
Anaplastic Thyroid Cancer, ATC
Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HLX208
Sponsored by
About this trial
This is an interventional treatment trial for Anaplastic Thyroid Cancer
Eligibility Criteria
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.
Sites / Locations
- Fudan University Affiliated Oncology Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HLX208
Arm Description
Participants receive HLX208 450mg bid po
Outcomes
Primary Outcome Measures
ORR
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
Secondary Outcome Measures
PFS
Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )
OS
Overall survival
Full Information
NCT ID
NCT05102292
First Posted
October 20, 2021
Last Updated
August 16, 2023
Sponsor
Shanghai Henlius Biotech
1. Study Identification
Unique Protocol Identification Number
NCT05102292
Brief Title
The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to assess efficacy, safety and PK in anaplastic thyroid cancer (ATC) given HLX208 (BRAF V600E inhibitor).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Thyroid Cancer, ATC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HLX208
Arm Type
Experimental
Arm Description
Participants receive HLX208 450mg bid po
Intervention Type
Drug
Intervention Name(s)
HLX208
Other Intervention Name(s)
BRAF V600E inhibitor
Intervention Description
HLX208 450mg bid po
Primary Outcome Measure Information:
Title
ORR
Description
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
PFS
Description
Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )
Time Frame
from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Title
OS
Description
Overall survival
Time Frame
from the date of first dose until the date of death from any cause，assessed up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fudan University Affiliated Oncology Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation
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