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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05528406
• Other study ID #: HLX208-ST201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 20, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: September 2022
• Source: Shanghai Henlius Biotech
• Contact: Xiaohua Wu, PhD
• Phone: 021-34778299
• Email: Wu.xh[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 1, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• HLX208
900mg bid po

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective response rate(assessed by independent radiological review committee (IRRC) based on the e RECIST Version 1.1)	from first dose to the last patient was followed up for 6 month
Secondary	PFS	Progression-free survival(PFS):assessed by IRRC and the investigator based on the RECIST Version 1.1	[Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 1 years]
Secondary	DOR	Duration of response	[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]
Secondary	OS	Overall survival	[Time Frame: from the first dose to the time of death due to any cause,assessed up to 2 years]