Clinical trial
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)
Name
HLX208-mCRC201（BECOMES）
Description
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
Trial arms
Trial start
2021-08-11
Estimated PCD
2024-06-15
Trial end
2025-01-15
Status
Active (not recruiting)
Phase
Early phase I
Treatment
HLX208
HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
Arms:
Never use other BRAF inhibitor therapy, PD after other BRAF inhibitor therapy N=5~40, SD but intolerant after other BRAF inhibitor therapy
Other names:
BRAF V600E inhibitor
Cetuximab Injection [Erbitux]
Cetuximab 500 mg/m2 IV Q2W
Arms:
Never use other BRAF inhibitor therapy, PD after other BRAF inhibitor therapy N=5~40, SD but intolerant after other BRAF inhibitor therapy
Size
50
Primary endpoint
ORR
up to 2 years
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-08-21
1 organization
2 products
1 indication
Organization
Shanghai Henlius BiotechProduct
CetuximabIndication
Colorectal cancerProduct
HLX208