- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05263453
HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation
May 29, 2023 updated by: Shanghai Kechow Pharma, Inc.
A Single-arm, Multi-center Phase II Trial to Evaluate the Efficacy and Safety of the Combination of HL-085 and Vemurafenib in Advanced Melanoma Patients With BRAF V600E/K Mutation
The main purpose of this study is to Evaluate the Efficacy and Safety of the combination of HL-085 and Vemurafenib in Advanced Melanoma Patients with BRAF V600E/K Mutation.
This study includes IIa and IIb phase.
Phase IIa will determine the dose regiment for Phase IIb.
Phase IIb part will evaluate the efficacy and safety with this combination regiment.
Study Overview
Detailed Description
This is a single-arm, multi-center Phase II trial to evaluate the efficacy and safety of the combination of HL-085 and Vemurafenib in advanced melanoma patients with BRAF V600E/K mutation.
There are two phase of this study ( IIa and IIb).
Phase IIa will be evaluating the safety and efficacy of the combination regiment (HL-08512mg +Vemurafenib 720mg, and/or some lower dose regiment, such as 9mg+720mg) in 20-30 patients, and final determine the recommended dose regiment for Phase IIb.
In Phase IIb will enrolled 74 patients , the primary endpoint is ORR, and the secondary endpoint are PFS.
The safety profile of this combined HL-085/Vemurafenib regimen will be monitored during both phases.
The treatment period consists of 21-day cycles until progression or unacceptable toxicity occurs.
Study Type
Interventional
Enrollment (Estimated)
104
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhimei Zhu, Master
- Phone Number: 86 215201345822
- Email: zhuzm@kechowpharma.com
Study Contact Backup
- Name: Hongqi Tian
- Email: tianhq@kechowpharma.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
Contact:
- Jun Guo, M.D.
- Phone Number: +86-10-88121122
- Email: guoj307@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female patients ≥ 18 years of age;
- Patients with histological confirmed advanced melanoma;
- BRAF V600E/ V600K mutation positive;
- At least 1 site of radiographically measurable disease by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 1;
- Life expectancy ≥ 3 months;
- Can swallow the medicine,
- UCG documenting LVEF ≥50% within seven days prior to initiation of dosing;
- Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet count ≥ 1.0 x lower limit of normal (LLN); Hemoglobin ≥ 90 g/L; Serum creatinine ≤ 1.5 x upper limit of normal (ULN); Serum aspartate transaminase (AST) or serum alanine transaminase (ALT)≤ 2.5x ULN, and ≤ 5.0 x ULN if liver metastases are present. Serum alkaline phosphatase (ALP)≤ 2.5x ULN and ≥ 2.5 x ULN if bone metastases are present; Total serum bilirubin ≤ 1.5 x ULN; Serum albumin ≥ 30 g/L; Coagulation function:INR ≤1.5×ULN;Activated partial thrombin time (APTT) ≤1.5×ULN; Creatine kinase (CK) ≤1× ULN
- 10. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
- 11. Be willing and able to complete all the study procedures and follow-up examinations.
Exclusion Criteria:
- Patients who have been previously treated with a BRAF and/or MEK inhibitors.
- Patients with active CNS lesions are excluded (i.e. those with radiographically unstable, symptomatic lesions). However, patients treated with stereotactic therapy or surgeries are eligible if patient remains without evidence of disease progression in brain ≥ 3 months.
- Patients accepted other administration of anti-cancer study therapies within 4 weeks prior to initiation of dosing;
- Dysphagia,refractory nausea, vomiting, small bowel resection or any other gastrointestinal ailment that would preclude study drug absorption.
- Major surgery or traumatic injury (exclude baseline biopsy ) within 14 days prior to first dose of study treatment
- Patients have mean QTcB interval ≥ 480 msec, or any history of congenital long QT syndrome or with ongoing concomitant treatment with medications that prolong the QT interval at screening;
- Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, uncontrolled hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), bleeding disorders, symptomatic autoimmune diseases, severe obstructive or restrictive pulmonary diseases, uncontrolled endocrine disorders (hypothyroidism, hyperthyroidism and diabetes mellitus), retinopathy, active systemic infections, and inflammatory bowel disorders. This includes known HIV or AIDS-related illness, or active HBV and HCV.
- Active infection or antibiotics within one-week prior to study, including unexplained fever
- Lactating females or pregnant females.
- Systemic steroid or other immunosuppressive therapy within 4 weeks of starting the study.
- Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the principal investigator, could prevent adequate informed consent or compromise participation in the clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HL-085+Vemurafenib
HL-085 12mg BID+Vemurafenib 720mg BID combination therapy
|
HL-085 capsule 12mg administered orally twice daily in a 21-day treatment cycle
Vemurafenib tablet 720mg administered orally twice daily in a 21-day treatment cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: up to 24 months
|
Objective response rate (ORR)as measure of efficacy by RECIST 1.1
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free survival (PFS)
Time Frame: up to 24 months
|
Defined as the time from first dosing (C1D1) to date of first observed progression or death from any cause (whichever comes first)
|
up to 24 months
|
Disease control rate(DCR)
Time Frame: up to 24 months
|
Defined as the percentage of patients who have achieved a confirmed response of at least CR or PR or a response of SD
|
up to 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grade 3, 4, 5 toxicities
Time Frame: up to 24 months
|
Reporting of all grade 3, 4, 5 toxicities
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Hongqi Tian, Ph.D, Shanghai Kechow Pharma, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2021
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
February 21, 2022
First Submitted That Met QC Criteria
February 21, 2022
First Posted (Actual)
March 2, 2022
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 29, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HL-085-102-II-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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