Solid TumorPhase 1NCT03781219
A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation
A Phase 1 study testing HL-085 and Vemurafenib in people with Solid Tumor, run by Shanghai Kechow Pharma, Inc. at 4 sites in China.
Trial summary
This is a phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by HL-085 plus Vemurafenib treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor
- 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
- 45 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jul 2018to 1 Dec 2023
- Phase
- Phase 1
- 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
- BRAF V600 mutation in solid tumor.
- One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.
- 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
- Hypersensitivity to study drug ingredients or their analogues.
- Prior therapy with MEK-inhibitor.
- Receiving any other anti-cancer therapy at the same time .
- Active central nervous system (CNS) lesion.
- Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment.
- ECG QTcB≥480msec in screening, or history of congenital long QT syndrome；
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- Uncontrolled concomitant diseases or infectious diseases.
- 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 increase the risk of study and influence the result.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Yuankai Shi, M.D
- Recruiting
Beijing Oncology Hospital
Beijing, Beijing Municipality
- Recruiting
First Affiliated Hospital, Medicine School of Zhejiang University
Hangzhou, Zhejiang
- Recruiting
Henan Province Oncology Hospital
Zhengzhou, Henan
About this study
Official title: A Phase I, Single Arm, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 Plus Vemurafenib in Patients With BRAF V600 Mutant Advanced Solid Tumor
This is a phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by HL-085 plus Vemurafenib treatment.
- Conditions
- Solid Tumor
- Being tested
- HL-085, Vemurafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL-085Drug
HL-085 ( Capsule) is one MEK inhibitor.
VemurafenibDrug
Also called ZELBORAF
Vemurafenib ( Tablet) is BRAF inhibitor,
| Study group | Role | What they receive |
|---|---|---|
| HL-085 plus Vemurafenib | Experimental | HL-085 will be administered as BID with specified dose. And the Vemurafenib will be taken as the instruction in the label ( 960 mg, BID) Receives: Drug: HL-085; Drug: Vemurafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.
Measured: up to 12 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jul 2018
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
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 Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- If no Dose-limiting toxicity (DLT) occurs in the first three subjects in Cycle 1, the dose will be escalated to the next dose level; If a DLT occurs in one of the first three subjects, three additional subjects will be enrolled for the same dose cohort, and undergo the same procedures. Dose -escalation is performed based on the scheduled dose groups until DLT occurs in two or more subjects in a dose group which consists of 3 or 6 subjects.
- Masking
- None (open label)
- Enrolment
- 45 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 director, Shanghai Kechow Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781219
- Sponsor's protocol ID
- HL-085-102
- Status last verified
- May 2023
- First submitted
- 1 Mar 2018
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shi Y, Han X, Zhao Q, Zheng Y, Chen J, Yu X, Fang J, Liu Y, Huang D, Liu T, Shen H, Luo S, Yu H, Cao Y, Zhang X, Hu P. Tunlametinib (HL-085) plus vemurafenib in patients with advanced BRAF V600-mutant solid tumors: an open-label, single-arm, multicenter, phase I study. Exp Hematol Oncol. 2024 Jun 12;13(1):60. doi: 10.1186/s40164-024-00528-0.
PubMed 38867257
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, Single Arm, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 Plus Vemurafenib in Patients With BRAF V600 Mutant Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT03781219
- Acronym / sponsor ID
- HL-085-102
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Kechow Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 19 Dec 2018 (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, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by HL-085 plus Vemurafenib treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- If no Dose-limiting toxicity (DLT) occurs in the first three subjects in Cycle 1, the dose will be escalated to the next dose level; If a DLT occurs in one of the first three subjects, three additional subjects will be enrolled for the same dose cohort, and undergo the same procedures. Dose -escalation is performed based on the scheduled dose groups until DLT occurs in two or more subjects in a dose group which consists of 3 or 6 subjects.
| Arm | Type | Receives |
|---|---|---|
| HL-085 plus Vemurafenib | Experimental | Drug: HL-085, Drug: VemurafenibHL-085 will be administered as BID with specified dose. And the Vemurafenib will be taken as the instruction in the label ( 960 mg, BID) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- BRAF V600 mutation in solid tumor.
- One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.
- 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.
Key exclusion criteria (12 listed)
- Hypersensitivity to study drug ingredients or their analogues.
- Prior therapy with MEK-inhibitor.
- Receiving any other anti-cancer therapy at the same time .
- Active central nervous system (CNS) lesion.
- Bleeding symptoms at Grade 3 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 ( Capsule) is one MEK inhibitor. | Drug | HL-085 plus Vemurafenib |
| VemurafenibAlso: ZELBORAFVemurafenib ( Tablet) is BRAF inhibitor, | Drug | HL-085 plus Vemurafenib |
Primary outcome
Number of Adverse Events
Time frame: up to 12 mouths
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.
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.
- Derived from this study: PubMed 38867257Shi Y, Han X, Zhao Q, Zheng Y, Chen J, Yu X, Fang J, Liu Y, Huang D, Liu T, Shen H, Luo S, Yu H, Cao Y, Zhang X, Hu P. Tunlametinib (HL-085) plus vemurafenib in patients with advanced BRAF V600-mutant solid tumors: an open-label, single-arm, multicenter, phase I study. Exp Hematol Oncol. 2024 Jun 12;13(1):60. doi: 10.1186/s40164-024-00528-0.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HL-085 and Vemurafenib in people with Solid Tumor, run by Shanghai Kechow Pharma, Inc. at 4 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 8 inclusion and 12 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 4 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 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.
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 Jin Ma, Bachelor (86 13810268600, maj@kechowpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: up to 12 mouths). 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 NCT03781219, 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.