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

NCT05528406 | Unknown Phase 2

• 1 other identifier: HLX208-ST201
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• PFS

  [Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 1 years]

• 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]

• OS

  [Time Frame: from the first dose to the time of death due to any cause，assessed up to 2 years]

Study Arms (1)

HLX208

EXPERIMENTAL

Drug: HLX208

Interventions

HLX208 DRUG

900mg bid po

HLX208

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Central Study Contacts

Xiaohua Wu, PhD

CONTACT

021-34778299; Wu.xh@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 6, 2022
• Study Start: October 20, 2022
• Primary Completion: October 30, 2024
• Study Completion: June 1, 2025
• Last Updated: September 6, 2022

Record last verified: 2022-09