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

Henlius Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Metastatic Colorectal Cancer; mCRC

Treatments: Drug: HLX208

Study type: Interventional

Funder types: Industry

Identifiers

NCT05127759

HLX208-mCRC202

Details and patient eligibility

About

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

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age>=18Y;
2. Good Organ Function;
3. Expected survival time ≥ 3 months;
4. Metastatic/recurrent advanced BRAF V600E mCRC that have been diagnosed histologically and have failed first line treatment;
5. At least one measurable lesion as per RECIST v1.1;
6. ECOG score 0-1.

Exclusion criteria

1. Previous treatment with BRAF inhibitors or MEK inhibitors
2. 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).
3. Active clinical severe infection;
4. 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

HLX208

Experimental group

Description:

Participants receive HLX208 450mg bid po

Treatment:

Drug: HLX208