Back to resultsThe Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment
Primary Purpose
CRC
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HLX208
Cetuximab Injection [Erbitux]
Sponsored by
About this trial
This is an interventional treatment trial for CRC
Eligibility Criteria
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.
Sites / Locations
- Fudan University Affiliated Oncology Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Never use other BRAF inhibitor therapy
PD after other BRAF inhibitor therapy N=5~40
SD but intolerant after other BRAF inhibitor therapy
Arm Description
Never use other BRAF inhibitor therapy
PD after other BRAF inhibitor therapy
SD but intolerant after other BRAF inhibitor therapy
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
NCT04984369
First Posted
July 27, 2021
Last Updated
August 16, 2023
Sponsor
Shanghai Henlius Biotech
1. Study Identification
Unique Protocol Identification Number
NCT04984369
Brief Title
The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line 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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
January 15, 2025 (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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CRC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Never use other BRAF inhibitor therapy
Arm Type
Experimental
Arm Description
Never use other BRAF inhibitor therapy
Arm Title
PD after other BRAF inhibitor therapy N=5~40
Arm Type
Experimental
Arm Description
PD after other BRAF inhibitor therapy
Arm Title
SD but intolerant after other BRAF inhibitor therapy
Arm Type
Experimental
Arm Description
SD but intolerant after other BRAF inhibitor therapy
Intervention Type
Drug
Intervention Name(s)
HLX208
Other Intervention Name(s)
BRAF V600E inhibitor
Intervention Description
HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
Intervention Type
Drug
Intervention Name(s)
Cetuximab Injection [Erbitux]
Intervention Description
Cetuximab 500 mg/m2 IV Q2W
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
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.
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 of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment
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