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

CRC Clinical Trial

Official title:

An Open, Multicenter Phase II Clinical Study to Evaluate Safety and Efficacy of HLX208 (BRAF V600E Inhibitor) Combined With Cetuximab in Patients With Metastatic Colorectal Cancer (mCRC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04984369
• Other study ID #: HLX208-mCRC201(BECOMES)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 11, 2021
• Est. completion date: January 15, 2025

Study information

• Verified date: August 2023
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 15, 2025
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• CRC

Intervention

Drug:
• HLX208
HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
• Cetuximab Injection [Erbitux]
Cetuximab 500 mg/m2 IV Q2W

Locations

Country	Name	City	State
China	Fudan University Affiliated Oncology Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)	up to 2 years
Secondary	PFS	Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )	from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years]
Secondary	OS	Overall survival	from the date of first dose until the date of death from any cause,assessed up to 2 years