The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment

• Sponsor: Shanghai Henlius Biotech (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05092802
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29.2
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for refractory primary brain tumors with BRAF mutation

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor, Primary	Drug: HLX208	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Refractory Primary Brain Tumors With BRAF Mutation
• Actual Study Start Date: Dec 23, 2021
• Anticipated Primary Completion Date: May 30, 2023
• Anticipated Study Completion Date: May 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HLX208	Drug: HLX208; 450mg bid po

Outcome Measures

Primary Outcome Measures

1. 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 RANO

Secondary Outcome Measures

1. PFS [from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，an average of about 1 year]

   Progression-free survival(PFS):assessed by IRRC and the investigator based on the RANO

2. DOR [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)，an average of about 1 year]

   Duration of response

3. OS [from the first dose to the time of death due to any cause，an average of about 2 year]

   Overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age>=18Y

• Good Organ Function

• Expected survival time ≥ 3 months

• Refractory primary brain tumors with BRAF mutation that have been diagnosed

• Unable to receive surgery/radiotherapy, or have treatment failed after surgery/radiotherapy

• ECOG score 0-1;

Exclusion Criteria:

• Previous treatment with BRAF inhibitors or MEK inhibitors

• A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery

• Severe active infections requiring systemic anti-infective therapy

• Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital Affiliated to Shandong first medical University	Jinan	Shandong	China	250117

Sponsors and Collaborators

• Shanghai Henlius Biotech

Investigators

• Principal Investigator: Jinming Yu, Cancer Hospital Affiliated to Shandong first medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Henlius Biotech
• ClinicalTrials.gov Identifier: NCT05092802
• Other Study ID Numbers: HLX208-BT201
• First Posted: Oct 26, 2021
• Last Update Posted: May 3, 2022
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Neoplasms

Study Results

No Results Posted as of May 3, 2022