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

Program Status

Active, not recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

Cetuximab Injection [Erbitux], HLX208

Tags

MSS/ MMRp

Comments

For BRAF mutant CRC, after failure of first line treatment. Targeted therapy.

Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor medication used for the treatment of metastatic colorectal cancer (and head and neck cancer). It is mainly used in KRAS wild type metastatic CRC.

HLX208 – trial medication that is a BRAF V600E Inhibitor

Location Location Status
China
Fudan University Affiliated Oncology Hospital
Shanghai
Active, not recruiting

Inclusion 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

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.

NCT ID

NCT04984369

Date Trial Added

2021-07-30

Updated Date

2023-08-21