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

NCT04984369 | Unknown Phase 2

• 1 other identifier: HLX208-mCRC201（BECOMES）
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CRC

Outcome Measures

Primary Outcomes (1)

• ORR

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

  up to 2 years

Secondary Outcomes (2)

• 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

Study Arms (3)

Never use other BRAF inhibitor therapy

EXPERIMENTAL

Never use other BRAF inhibitor therapy

Drug: HLX208; Drug: Cetuximab Injection [Erbitux]

PD after other BRAF inhibitor therapy N=5~40

EXPERIMENTAL

PD after other BRAF inhibitor therapy

Drug: HLX208; Drug: Cetuximab Injection [Erbitux]

SD but intolerant after other BRAF inhibitor therapy

EXPERIMENTAL

SD but intolerant after other BRAF inhibitor therapy

Drug: HLX208; Drug: Cetuximab Injection [Erbitux]

Interventions

HLX208 DRUG

HLX208 450mg bid po OR 600mg bid po OR 900mg bid po

Also known as: BRAF V600E inhibitor

Never use other BRAF inhibitor therapy; PD after other BRAF inhibitor therapy N=5~40; SD but intolerant after other BRAF inhibitor therapy

Cetuximab Injection [Erbitux] DRUG

Cetuximab 500 mg/m2 IV Q2W

Never use other BRAF inhibitor therapy; PD after other BRAF inhibitor therapy N=5~40; SD but intolerant after other BRAF inhibitor therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Fudan University Affiliated Oncology Hospital

Shanghai, China

Location

MeSH Terms

Interventions

CCT239065; Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: July 30, 2021
• Study Start: August 11, 2021
• Primary Completion: June 15, 2024
• Study Completion: January 15, 2025
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)