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

• Status: Recruiting
• Trial end date: 2023-08-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Henlius Biotech
• Treatments: Cetuximab

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.