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

Metastatic Colorectal Cancer Clinical Trial

Official title:

An Open Label, Multicenter Phase II Clinical Study to Evaluate Efficacy , Safety and PK of HLX208 in Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05127759
• Other study ID #: HLX208-mCRC202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 23, 2022
• Est. completion date: June 28, 2025

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: June 28, 2025
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• mCRC
• Metastatic Colorectal Cancer

Intervention

Drug:
• HLX208
HLX208 450mg bid po

Locations

Country	Name	City	State
China	Liaoning Cancer Hospital	Shenyang	Liaoning

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