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

Primary Purpose

Metastatic Colorectal Cancer, mCRC

Status

Active

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

HLX208

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age>=18Y;
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.

Exclusion Criteria:

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.

Sites / Locations

Liaoning Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HLX208

Arm Description

Participants receive HLX208 450mg bid po

Outcomes

Primary Outcome Measures

ORR

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

Secondary Outcome Measures

PFS

Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )

Overall survival

Full Information

NCT ID

NCT05127759

First Posted

November 9, 2021

Last Updated

August 7, 2023

Sponsor

Shanghai Henlius Biotech

1. Study Identification

Unique Protocol Identification Number

NCT05127759

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 23, 2022 (Actual)

Primary Completion Date

January 30, 2024 (Anticipated)

Study Completion Date

June 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Henlius Biotech

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer, mCRC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HLX208

Arm Type

Experimental

Arm Description

Participants receive HLX208 450mg bid po

Intervention Type

Drug

Intervention Name(s)

HLX208

Other Intervention Name(s)

BRAF V600E inhibitor

Intervention Description

HLX208 450mg bid po

Primary Outcome Measure Information:

Title

ORR

Description

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

Time Frame

up to 2 years

Secondary Outcome Measure Information:

Title

PFS

Description

Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )

Time Frame

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

Title

Description

Overall survival

Time Frame

from the date of first dose until the date of death from any cause，assessed up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age>=18Y; 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

Liaoning Cancer Hospital

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110042

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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