The Efficacy and Safety of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation

• Status: Not yet recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess efficacy, safety and PK in metastatic colorectal cancer (mCRC) given HLX208 (BRAF V600E inhibitor).

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

Details

• Lead Sponsor: Shanghai Henlius Biotech

Criteria

Inclusion Criteria:

1. Age>=18Y;

2. Good Organ Function;

3. Expected survival time ≥ 3 months;

4. Metastatic/recurrent advanced BRAF V600E mCRC that have been diagnosed histologically and have failed first line treatment;

5. At least one measurable lesion as per RECIST v1.1;

6. ECOG score 0-1.

Exclusion Criteria:

1. Previous treatment with BRAF inhibitors or MEK inhibitors

2. Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).

3. Active clinical severe infection;

4. A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.