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

Henlius Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: CRC

Treatments: Drug: Cetuximab Injection [Erbitux]; Drug: HLX208

Study type: Interventional

Funder types: Industry

Identifiers

NCT04984369

HLX208-mCRC201（BECOMES）

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Never use other BRAF inhibitor therapy

Experimental group

Description:

Never use other BRAF inhibitor therapy

Treatment:

Drug: HLX208

Drug: Cetuximab Injection [Erbitux]

PD after other BRAF inhibitor therapy N=5~40

Experimental group

Description:

PD after other BRAF inhibitor therapy

Treatment:

Drug: HLX208

Drug: Cetuximab Injection [Erbitux]

SD but intolerant after other BRAF inhibitor therapy

Experimental group

Description:

SD but intolerant after other BRAF inhibitor therapy

Treatment:

Drug: HLX208

Drug: Cetuximab Injection [Erbitux]