MelanomaPhase 1/2NCT03973151
Study of HL-085 in NRAS Mutant Advanced Melanoma
A Phase 1/2 study testing HL-085 in people with Melanoma, run by Shanghai Kechow Pharma, Inc. at 2 sites in China.
Trial summary
This is a phase I/II, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with NRAS mutant advanced melanoma . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melanoma
- What is being tested?
- HL-085
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2017to 18 Jan 2021
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed unresectable Stage III or Stage IV melanoma according to AJCC (Version 7, 2010).
- Subjects must have NRAS mutation in melanoma.
- Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment.
- ECOG performance status of 0-1.
- Life expectancy ≥ 3 months.
- Ability to take the medicine orally.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior therapy with a MEK-inhibitor
- Patients with known hypersensitivity to study drug ingredients or their analogues.
- Active central nervous system (CNS) lesion.
- ECG QTcB≥480msec in screening, or history of congenital long QT syndrome.
- Subjects with bleeding symptoms at Grade 3 (NCI-CTCAE v4.03) within 4 weeks prior to starting study treatment.
- Uncontrolled concomitant diseases or infectious diseases.
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- Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).
- History of HIV,HCV,HBV infection.
- Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.
- Serum HCG test is positive.
- Other conditions that influence the results and increase the risk of study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: A Phase I/II, Single Arm, Dose Escalation and Cohort Expansion Study to Evaluate Safety, Preliminary Efficacy of HL-085 in Patients With NRAS Mutant Advanced Melanoma
This is a phase I/II, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with NRAS mutant advanced melanoma .
- Conditions
- Melanoma
- Being tested
- HL-085
- Keywords
- Melanoma, NRAS
- 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 is one MEK inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| HL-085 | Experimental | HL-085 will be administered as BID with specified dose. Receives: Drug: HL-085 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 during the study period
Measured: Duration of the study, estimated to be approximately 24 months.
Maximum tolerated dose (MTD)
The dose level immediately below the dose level at which ≥ 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity (DLT)
Measured: DLTs within the first cycle of therapy (up to 35 days)
Secondary outcomes (5)
Objective Response Rate (ORR) as measure of efficacy
Efficacy estimated as the Objective Response Rate (ORR) , which is the sum of Partial Response (PR) and Complete Response (CR) as determined by RECIST 1.1
Measured: Duration of the study, estimated to be approximately 24 months.
Area under the plasma concentration versus time curve (AUC)
AUC of HL-085 following single and repeated dosing
Measured: Duration of the study, estimated to be approximately 24 months
Peak Plasma Concentration (Cmax)
Cmax of HL-085 following single and repeated dosing
Measured: Duration of the study, estimated to be approximately 24 months
Time to maximum observed plasma drug concentration (Tmax)
Tmax of HL-085 following single and repeated dosing
Measured: Duration of the study, estimated to be approximately 24 months.
Half-life (T1/2)
T1/2 of HL-085 following single and repeated dosing
Measured: Duration of the study, estimated to be approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Sep 2017
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Kechow Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongqi Tian, Ph.D, Study director, Shanghai Kechow Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973151
- Sponsor's protocol ID
- HL-085-101
- Status last verified
- May 2023
- First submitted
- 19 Dec 2017
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang X, Luo Z, Chen J, Chen Y, Ji D, Fan L, Chen L, Zhao Q, Hu P, Sun P, Jia Z, Guo J, Si L. First-in-human phase I dose-escalation and dose-expansion trial of the selective MEK inhibitor HL-085 in patients with advanced melanoma harboring NRAS mutations. BMC Med. 2023 Jan 4;21(1):2. doi: 10.1186/s12916-022-02669-7.
PubMed 36600247
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 Phase I/II, Single Arm, Dose Escalation and Cohort Expansion Study to Evaluate Safety, Preliminary Efficacy of HL-085 in Patients With NRAS Mutant Advanced Melanoma
- ClinicalTrials.gov ID
- NCT03973151
- Acronym / sponsor ID
- HL-085-101
- Conditions
- Melanoma
- Keywords
- Melanoma, NRAS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Shanghai Kechow Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 4 Jun 2019 (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.
This is a phase I/II, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with NRAS mutant advanced melanoma .
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 | Experimental | Drug: HL-085HL-085 will be administered as BID with specified dose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed unresectable Stage III or Stage IV melanoma according to AJCC (Version 7, 2010).
- Subjects must have NRAS mutation in melanoma.
- Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment.
- ECOG performance status of 0-1.
- Life expectancy ≥ 3 months.
Key exclusion criteria (11 listed)
- Prior therapy with a MEK-inhibitor
- Patients with known hypersensitivity to study drug ingredients or their analogues.
- Active central nervous system (CNS) lesion.
- ECG QTcB≥480msec in screening, or history of congenital long QT syndrome.
- Subjects with bleeding symptoms at Grade 3 (NCI-CTCAE v4.03) within 4 weeks prior to starting 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 is one MEK inhibitor. | Drug | HL-085 |
Primary outcome
Number of participants with adverse events
Time frame: Duration of the study, estimated to be approximately 24 months.
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 during the study period
Maximum tolerated dose (MTD)
Time frame: DLTs within the first cycle of therapy (up to 35 days)
The dose level immediately below the dose level at which ≥ 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity (DLT)
5 secondary outcomes
Objective Response Rate (ORR) as measure of efficacy
Time frame: Duration of the study, estimated to be approximately 24 months.
Area under the plasma concentration versus time curve (AUC)
Time frame: Duration of the study, estimated to be approximately 24 months
Peak Plasma Concentration (Cmax)
Time frame: Duration of the study, estimated to be approximately 24 months
Time to maximum observed plasma drug concentration (Tmax)
Time frame: Duration of the study, estimated to be approximately 24 months.
Half-life (T1/2)
Time frame: Duration of the study, estimated to be approximately 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 36600247Wang X, Luo Z, Chen J, Chen Y, Ji D, Fan L, Chen L, Zhao Q, Hu P, Sun P, Jia Z, Guo J, Si L. First-in-human phase I dose-escalation and dose-expansion trial of the selective MEK inhibitor HL-085 in patients with advanced melanoma harboring NRAS mutations. BMC Med. 2023 Jan 4;21(1):2. doi: 10.1186/s12916-022-02669-7.
- 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, Ph.D study director
Shanghai Kechow Pharma, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HL-085 in people with Melanoma, run by Shanghai Kechow Pharma, Inc. at 2 sites 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 7 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: finished, 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 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Duration of the study, estimated to be approximately 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973151, which also lists 1 linked publication.
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.