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The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation

Sponsor
Shanghai Henlius Biotech (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05102292
Collaborator
(none)
25
Enrollment
1
Location
1
Arm
36.7
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 10, 2021
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: HLX208

Participants receive HLX208 450mg bid po

Drug: HLX208
HLX208 450mg bid po
Other Names:
  • BRAF V600E inhibitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ORR [up to 2 years]

      Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)

    Secondary Outcome Measures

    1. PFS [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 )

    2. OS [from the date of first dose until the date of death from any cause，assessed up to 2 years]

      Overall survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age>=18Y;

    2. Good Organ Function;

    3. Expected survival time ≥ 3 months;

    4. Advanced BRAF V600 ATC that have been diagnosed histologically;

    5. At least one measurable lesion as per RECIST v1.1;

    6. ECOG score 0-1.

    Exclusion Criteria:

    1. Pregnant or lactating women;

    2. Previous treatment with BRAF inhibitors or MEK inhibitors;

    3. A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin;

    4. Severe active infections requiring systemic anti-infective therapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Affiliated Oncology Hospital Shanghai China

    Sponsors and Collaborators

    • Shanghai Henlius Biotech

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Henlius Biotech
    ClinicalTrials.gov Identifier:
    NCT05102292
    Other Study ID Numbers:
    • HLX208-ATC201
    First Posted:
    Nov 1, 2021
    Last Update Posted:
    Jan 4, 2022
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Thyroid Neoplasms
    Thyroid Carcinoma, Anaplastic
    Thyroid Diseases

    Study Results

    No Results Posted as of Jan 4, 2022