HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    104
  • sponsor
    Shanghai Kechow Pharma, Inc.
Updated on 29 April 2022
platelet count
measurable disease
BRAF
neutrophil count
vemurafenib
advanced melanoma
braf v600e mutation

Summary

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.

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.

Details
Condition Melanoma
Treatment Vemurafenib, HL-085
Clinical Study IdentifierNCT05263453
SponsorShanghai Kechow Pharma, Inc.
Last Modified on29 April 2022

Eligibility

Yes No Not Sure

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
\. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures
\. 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note