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

NCT ID: NCT04984369

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-11
• Study Completion Date: 2025-01-15

Brief 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

Conditions

CRC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Never use other BRAF inhibitor therapy

Never use other BRAF inhibitor therapy

Group Type: EXPERIMENTAL

HLX208

Intervention Type: DRUG

HLX208 450mg bid po OR 600mg bid po OR 900mg bid po

Cetuximab Injection [Erbitux]

Intervention Type: DRUG

Cetuximab 500 mg/m2 IV Q2W

PD after other BRAF inhibitor therapy N=5~40

PD after other BRAF inhibitor therapy

Group Type: EXPERIMENTAL

HLX208

Intervention Type: DRUG

HLX208 450mg bid po OR 600mg bid po OR 900mg bid po

Cetuximab Injection [Erbitux]

Intervention Type: DRUG

Cetuximab 500 mg/m2 IV Q2W

SD but intolerant after other BRAF inhibitor therapy

SD but intolerant after other BRAF inhibitor therapy

Group Type: EXPERIMENTAL

HLX208

Intervention Type: DRUG

HLX208 450mg bid po OR 600mg bid po OR 900mg bid po

Cetuximab Injection [Erbitux]

Intervention Type: DRUG

Cetuximab 500 mg/m2 IV Q2W

Interventions

HLX208

HLX208 450mg bid po OR 600mg bid po OR 900mg bid po

Intervention Type: DRUG

Cetuximab Injection [Erbitux]

Cetuximab 500 mg/m2 IV Q2W

Intervention Type: DRUG

Other Intervention Names

BRAF V600E inhibitor

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Affiliated Oncology Hospital

Shanghai, , China

Countries

China

Other Identifiers

HLX208-mCRC201（BECOMES）

Identifier Type: -

Identifier Source: org_study_id