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


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

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 15, 2022


  • Drug: HLX208
    • HLX208 450mg bid po
  • Drug: Cetuximab Injection [Erbitux]
    • Cetuximab 500 mg/m2 IV Q2W

Arms, Groups and Cohorts

  • Experimental: Never use other BRAF inhibitor therapy
    • Never use other BRAF inhibitor therapy
  • Experimental: PD after other BRAF inhibitor therapy N=5~40
    • PD after other BRAF inhibitor therapy
  • Experimental: SD but intolerant after other BRAF inhibitor therapy
    • SD but intolerant after other BRAF inhibitor therapy

Clinical Trial Outcome Measures

Primary Measures

  • ORR
    • Time Frame: up to 2 years
    • Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)

Secondary Measures

  • 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 )
  • OS
    • Time Frame: from the date of first dose until the date of death from any cause,assessed up to 2 years
    • Overall survival

Participating in This Clinical Trial

Inclusion Criteria

  • 18Y≤Age≤75Y 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; Expected survival time of more than 3 months; 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Henlius Biotech
  • Provider of Information About this Clinical Study
    • Sponsor

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