The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment

Sponsor
Shanghai Henlius Biotech (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04984369
Collaborator
(none)
50
1
3
24.1
2.1

Study Details

Study Description

Brief Summary

An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open, Multicenter Phase II Clinical Study to Evaluate Safety and Efficacy of HLX208 (BRAF V600E Inhibitor) Combined With Cetuximab in Patients With Metastatic Colorectal Cancer (mCRC)
Actual Study Start Date :
Aug 11, 2021
Anticipated Primary Completion Date :
Aug 15, 2022
Anticipated Study Completion Date :
Aug 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Never use other BRAF inhibitor therapy

Never use other BRAF inhibitor therapy

Drug: HLX208
HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
Other Names:
  • BRAF V600E inhibitor
  • Drug: Cetuximab Injection [Erbitux]
    Cetuximab 500 mg/m2 IV Q2W

    Experimental: PD after other BRAF inhibitor therapy N=5~40

    PD after other BRAF inhibitor therapy

    Drug: HLX208
    HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
    Other Names:
  • BRAF V600E inhibitor
  • Drug: Cetuximab Injection [Erbitux]
    Cetuximab 500 mg/m2 IV Q2W

    Experimental: SD but intolerant after other BRAF inhibitor therapy

    SD but intolerant after other BRAF inhibitor therapy

    Drug: HLX208
    HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
    Other Names:
  • BRAF V600E inhibitor
  • Drug: Cetuximab Injection [Erbitux]
    Cetuximab 500 mg/m2 IV Q2W

    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:
    • Age>=18Y

    • Good Organ Function

    • Expected survival time ≥ 3 months

    • Metastatic/recurrent advanced BRAF+ mCRC that have been diagnosed histologically and have failed first line treatment

    • ECOG score 0-1;

    Exclusion Criteria:
    • arm 1 : Previous treatment with BRAF inhibitors or MEK inhibitors

    • Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).

    • Active clinical severe infection;

    • 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 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:
    NCT04984369
    Other Study ID Numbers:
    • HLX208-mCRC201(BECOMES)
    First Posted:
    Jul 30, 2021
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Jul 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:

    Study Results

    No Results Posted as of Jan 12, 2022