A Phase II Clinical Trial to Evaluate HLX208 in Advanced Solid Tumor Patients With BRAF V600 Mutation

Henlius Pharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Solid Tumor

Treatments: Drug: HLX208

Study type: Interventional

Funder types: Industry

Identifiers

NCT05528406

HLX208-ST201

Details and patient eligibility

About

An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 (BRAF V600E Inhibitor) in Advanced Solid Tumor With BRAF V600 Mutation

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age>=18Y
• Good Organ Function
• Expected survival time ≥ 3 months
• advanced solid tumors with BRAF V600 mutation that have been diagnosed
• Previous failure to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
• ECOG score 0-1;

Exclusion criteria

• Previous treatment with BRAF inhibitors or MEK inhibitors
• Symptomatic brain or meningeal metastases (unless the patient has beenon > treatment for 6 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable)
• A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin
• Patient with non-small cell lung cancer, anaplastic thyroid cancer, malignant primary intracranial tumor, melanoma, colorectal cancer or hematological tumor（Vulva and vaginal melanoma are excluded.）
• Severe active infections requiring systemic anti-infective therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

HLX208

Experimental group

Treatment:

Drug: HLX208