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

August 16, 2023 updated by: Shanghai Henlius Biotech

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)

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Fudan University Affiliated Oncology Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Never use other BRAF inhibitor therapy
Drug: HLX208
HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
Other Names:
  • BRAF V600E inhibitor
Drug: Cetuximab Injection [Erbitux]
Cetuximab 500 mg/m2 IV Q2W
Experimental: PD after other BRAF inhibitor therapy N=5~40
PD after other BRAF inhibitor therapy
Drug: HLX208
HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
Other Names:
  • BRAF V600E inhibitor
Drug: Cetuximab Injection [Erbitux]
Cetuximab 500 mg/m2 IV Q2W
Experimental: SD but intolerant after other BRAF inhibitor therapy
Drug: HLX208
HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
Other Names:
  • BRAF V600E inhibitor
Drug: Cetuximab Injection [Erbitux]
Cetuximab 500 mg/m2 IV Q2W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: up to 2 years
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 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 )
from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years]
OS
Time Frame: from the date of first dose until the date of death from any cause，assessed up to 2 years
Overall survival
from the date of first dose until the date of death from any cause，assessed up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Henlius Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2021

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLX208-mCRC201（BECOMES）

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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