The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment
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
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:
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:
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:
Drug: Cetuximab Injection [Erbitux]
Cetuximab 500 mg/m2 IV Q2W
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 )
- 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
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.- HLX208-mCRC201(BECOMES)