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

Shanghai Henlius Biotech1 site in 1 country25 target enrollmentMarch 23, 2022

InterventionsHLX208

Overview

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

Registry

clinicaltrials.gov

Start Date

March 23, 2022

End Date

June 28, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Shanghai Henlius Biotech

Responsible Party

Sponsor

•Good Organ Function;
•Expected survival time ≥ 3 months;
•Metastatic/recurrent advanced BRAF V600E mCRC that have been diagnosed histologically and have failed first line treatment;
•At least one measurable lesion as per RECIST v1.1;
•ECOG score 0-1.

•Previous treatment with BRAF inhibitors or MEK inhibitors
•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).
•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.

Participants receive HLX208 450mg bid po

Intervention: HLX208

ORR

Time Frame: up to 2 years

Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)

PFS(from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years)
OS(from the date of first dose until the date of death from any cause，assessed up to 2 years)