MelanomaPhase 2NCT05263453
HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation
A Phase 2 study testing HL-085 and Vemurafenib in people with Melanoma, run by Shanghai Kechow Pharma, Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Melanoma
- What is being tested?
- HL-085 and Vemurafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2021to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Hongqi Tian contact
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, M.D., +86-10-88121122, guoj307@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- HL-085, Vemurafenib
- Keywords
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL-085Drug
HL-085 capsule 12mg administered orally twice daily in a 21-day treatment cycle
VemurafenibDrug
Vemurafenib tablet 720mg administered orally twice daily in a 21-day treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| HL-085+Vemurafenib | Experimental | HL-085 12mg BID+Vemurafenib 720mg BID combination therapy Receives: Drug: HL-085; Drug: Vemurafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate (ORR)as measure of efficacy by RECIST 1.1
Measured: up to 24 months
Secondary outcomes (2)
Progression Free survival （PFS）
Defined as the time from first dosing (C1D1) to date of first observed progression or death from any cause (whichever comes first)
Measured: up to 24 months
Disease control rate（DCR）
Defined as the percentage of patients who have achieved a confirmed response of at least CR or PR or a response of SD
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start6 Sep 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Kechow Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongqi Tian, Ph.D, Study chair, Shanghai Kechow Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263453
- Sponsor's protocol ID
- HL-085-102-II-01
- Status last verified
- May 2023
- First submitted
- 21 Feb 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05263453
- Acronym / sponsor ID
- HL-085-102-II-01
- Conditions
- Melanoma
- Keywords
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Shanghai Kechow Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HL-085+Vemurafenib | Experimental | Drug: HL-085, Drug: VemurafenibHL-085 12mg BID+Vemurafenib 720mg BID combination therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HL-085HL-085 capsule 12mg administered orally twice daily in a 21-day treatment cycle | Drug | HL-085+Vemurafenib |
| VemurafenibVemurafenib tablet 720mg administered orally twice daily in a 21-day treatment cycle | Drug | HL-085+Vemurafenib |
Primary outcome
Objective response rate (ORR)
Time frame: up to 24 months
Objective response rate (ORR)as measure of efficacy by RECIST 1.1
2 secondary outcomes
Progression Free survival （PFS）
Time frame: up to 24 months
Disease control rate（DCR）
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongqi Tian contact
Hongqi Tian, Ph.D study chair
Shanghai Kechow Pharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HL-085 and Vemurafenib in people with Melanoma, run by Shanghai Kechow Pharma, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhimei Zhu, Master (86 215201345822, zhuzm@kechowpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.