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

Phase 2

Not yet recruiting

• Conditions: Solid Tumor
• Interventions: Drug: HLX208

• Registration Number: NCT05528406
• Lead Sponsor: Shanghai Henlius Biotech

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Last Update Submitted: 2022-09-02
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06
• Study Start: 2022-10-20
• Primary Completion: 2024-10-30
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HLX208	HLX208	-

Primary Outcome Measures

Name	Time	Method
ORR	from first dose to the last patient was followed up for 6 month	Objective response rate(assessed by independent radiological review committee (IRRC) based on the e RECIST Version 1.1)

Secondary Outcome Measures

Name	Time	Method
PFS	[Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 1 years]	Progression-free survival(PFS):assessed by IRRC and the investigator based on the RECIST Version 1.1
OS	[Time Frame: from the first dose to the time of death due to any cause，assessed up to 2 years]	Overall survival
DOR	[Time Frame: from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first) assessed up to 1 years]	Duration of response