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

Estado del programa

Activo, no recluta

Fase

Fase 2

Inmunoterapia previa permitida

Ensayo dirigido por el CRC

Drogas

Cetuximab Injection [Erbitux], HLX208

Etiquetas

MSS/ MMRp

Comentarios

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

Ubicación Situación
China
Fudan University Affiliated Oncology Hospital
Shanghai
Activo, no recluta

Criterios de inclusión

Criterios de inclusión:

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;

Criterios de exclusión

Criterios de exclusión:

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

Fecha en que se añadió el juicio

2021-07-30

Fecha de actualización

2023-08-21