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The Efficacy and Safety of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation

Sponsor
Shanghai Henlius Biotech (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05127759
Collaborator
(none)
25
Enrollment
1
Location
1
Arm
35.3
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 metastatic colorectal cancer (mCRC) given HLX208 (BRAF V600E inhibitor).

Condition or Disease Intervention/Treatment Phase
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 II Clinical Study to Evaluate Efficacy , Safety and PK of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation
Actual Study Start Date :
Mar 23, 2022
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Feb 28, 2025

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. Metastatic/recurrent advanced BRAF V600E mCRC that have been diagnosed histologically and have failed first line treatment;

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

    6. ECOG score 0-1.

    Exclusion Criteria:

    1. Previous treatment with BRAF inhibitors or MEK inhibitors

    2. Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).

    3. Active clinical severe infection;

    4. A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Liaoning Cancer Hospital Shenyang Liaoning China 110042

    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:
    NCT05127759
    Other Study ID Numbers:
    • HLX208-mCRC202
    First Posted:
    Nov 19, 2021
    Last Update Posted:
    May 3, 2022
    Last Verified:
    Nov 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:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of May 3, 2022