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

Phase 2

Active, not recruiting

• Conditions: CRC
• Interventions: Drug: HLX208; Drug: Cetuximab Injection [Erbitux]

• Registration Number: NCT04984369
• Lead Sponsor: Shanghai Henlius Biotech

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-07-30
• Study Start: 2021-08-11
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21
• Primary Completion: 2024-06-15
• Study Completion: 2025-01-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PD after other BRAF inhibitor therapy N=5~40	Cetuximab Injection [Erbitux]	PD after other BRAF inhibitor therapy
Never use other BRAF inhibitor therapy	Cetuximab Injection [Erbitux]	Never use other BRAF inhibitor therapy
SD but intolerant after other BRAF inhibitor therapy	Cetuximab Injection [Erbitux]	SD but intolerant after other BRAF inhibitor therapy
Never use other BRAF inhibitor therapy	HLX208	Never use other BRAF inhibitor therapy
PD after other BRAF inhibitor therapy N=5~40	HLX208	PD after other BRAF inhibitor therapy
SD but intolerant after other BRAF inhibitor therapy	HLX208	SD but intolerant after other BRAF inhibitor therapy

Primary Outcome Measures

Name	Time	Method
ORR	up to 2 years	Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)

Secondary Outcome Measures

Name	Time	Method
OS	from the date of first dose until the date of death from any cause，assessed up to 2 years	Overall survival
PFS	from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years]	Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )

Trial Locations

Locations (1)

Fudan University Affiliated Oncology Hospital; 🇨🇳 Shanghai, China