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

NCT05114603 | Unknown Phase 2

• 1 other identifier: HLX208-MEL201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief Summary

An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation

Conditions

Advanced Melanoma

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

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

• 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) assessed up to 1 years

• OS

  from the first dose to the time of death due to any cause，assessed up to 2 years

Study Arms (2)

Dose-escalation stage

EXPERIMENTAL

Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding.

Drug: HLX208

Dose-expansion stage

EXPERIMENTAL

Patients with advanced melanoma will be enrolled in two expansion cohorts, at doses equal to or lower than the MTD, to better characterize the safety, tolerability, PK variability, and preliminary efficacy of single-agent HLX208.

Drug: HLX208

Interventions

HLX208 DRUG

level 1:600mg po Bid level 2:900mg po Bid

Dose-escalation stage; Dose-expansion stage

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 melanoma with BRAF V600 mutation that have been diagnosed
• 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 3 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinicalsymptoms are stable).
• Severe active infections requiring systemic anti-infective therapy
• A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (7)

Peking University Cancer Hospita

Beijing, Beijing Municipality, 100142, China

RECRUITING

Hunan cancer hospital

Changsha, China

RECRUITING

West China Hospital of Sichuan University

Chendu, China

NOT YET RECRUITING

Fujian cancer hospital

Fujian, China

NOT YET RECRUITING

Shangxi Bethune Hospita

Taiyuan, China

NOT YET RECRUITING

union Hospital Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

NOT YET RECRUITING

Henan cancer hospital

Zhengzhou, China

NOT YET RECRUITING

Central Study Contacts

Jun Guo

CONTACT

88196391; guoj307@126.com

Lu Si

CONTACT

88196391; silu15_silu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: March 21, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2024
• Last Updated: May 3, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)