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

Phase 2

Active, not recruiting

• Conditions: Metastatic Colorectal Cancer; mCRC
• Interventions: Drug: HLX208

• Registration Number: NCT05127759
• Lead Sponsor: Shanghai Henlius Biotech

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-19
• Study Start: 2022-03-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08
• Primary Completion: 2024-01-30
• Study Completion: 2025-06-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HLX208	HLX208	Participants receive HLX208 450mg bid po

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)

Liaoning Cancer Hospital; 🇨🇳 Shenyang, Liaoning, China