Solid Tumor, AdultPhase 1NCT03976050
Phase I Study of HL-085 in Patients With Advanced Solid Tumors
A Phase 1 study testing HL-085 in people with Solid Tumor, Adult, run by Shanghai Kechow Pharma, Inc. at 2 sites in United States.
Trial summary
The study drug, HL-085 is a MEK inhibitor with the potential indication for cancers. It is an oral medication to be given daily. The purposes of this study is to find answers to the following research questions: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- HL-085
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jun 2019to 12 Nov 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a pathologically documented solid tumor(s) that has relapsed from, or is refractory to standard treatment, or for which no standard treatment is available.
- Must have at least one measurable lesion as defined by RECISTv1.1 criteria for solid tumors.
- Must have received biological chemotherapy, immunotherapy or radiotherapy ≥4 weeks prior to starting the study treatment. Must have received small molecule chemotherapy ≥2 weeks or five half-lives (whichever is longer) prior to starting the study treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy ≥3 months (as judged by the Investigator).
- Must have adequate hematologic, hepatic and renal function.
Who cannot join
- Have undergone or plan to have major surgery or experienced severe trauma ≤28 days prior to starting the study treatment.
- Known hypersensitivity to IP ingredients or their analogues.
- Prior therapy with a MEK-inhibitor
- Receipt of any other investigational agent therapy within 4 weeks prior to starting study treatment.
- Any concurrent therapy for cancer treatment.
- Have active central nervous system lesion.
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- Receiving and unable to discontinue medication which are strong inducers, strong inhibitors or enzyme substrates of cytochrome P450 CYP2C9 and CYP2C19 from 14 days prior to treatment.
- Grade 3 bleeding symptoms (NCI-CTCAE v5.0) within 4 weeks prior to starting study treatment.
- Unable to swallow IP or has refractory nausea and vomiting, malabsorption, external biliary diversion, or any significant small bowel resection that may interfere with adequate absorption of IP.
- ECG QTcB≥480msec in screening, or history of congenital long QT syndrome.
- Left ventricular ejection fraction (LVEF) <50%.
- History major cerebrovascular diseases within 6 months prior to enrollment.
- Infectious diseases requiring systemic treatment.
- History or current evidence of retinal diseases.
- Have active/chronic infection with hepatitis C, or positive hepatitis B surface antigen (HBsAg), or active/chronic infection with human immunodeficiency virus (HIV).
- Known active tuberculosis.
- History of allogeneic bone marrow transplantation or organ transplantation.
- Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
- Pregnant or breast-feeding females.
- Previous or history of second malignancy within 5 years prior to study treatment
- Other conditions which may increase the risk associated with study participation, or interfere with the evaluation of study results.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Livestrong Cancer Institute, Dell Medical School, The University of Texas at Austin
Austin, Texas, 78712
Next Oncology
San Antonio, Texas, 78229
About this study
Official title: A Phase I, Single Arm, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 in Subjects With Advanced Solid Tumors
The study drug, HL-085 is a MEK inhibitor with the potential indication for cancers. It is an oral medication to be given daily.
The purposes of this study is to find answers to the following research questions:
- What is the highest tolerable dose of HL-085 that can be given to subjects when given orally (by mouth) on a twice daily basis?
- What are the side effects of HL-085?
- How much HL-085 is in the blood at specific times after dosing and how does the body get rid of the HL-085?
- Conditions
- Solid Tumor, Adult
- Being tested
- HL-085
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL-085Drug
Also called No other interventions
HL-085 is a MEK inhibitor with potential indication for cancers. it will be given twice daily continuously in the study until disease progression; or the risks outweigh the benefits, if the subject continues study treatment; or subjects with poor compliance; or subjects need to receive or have already started alternative anti-tumor drugs; or Subjects who need to receive or have already started alternative any other concomitant medication and/or treatment, which would significantly impact their safety; or interruption of IP administration for more than 14 days due to IP-related AEs.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Subjects in the dose escalation cohorts will receive ascending doses of HL-085 until the MTD is determined. The first three subjects will receive twice-daily doses (BID) of HL-085 6 mg. Additional cohorts may receive doses of HL-085 9, 12 or 18 mg BID respectively and sequentially. If DLTs are observed in <33.3% of subjects at the 18 mg dose. Receives: Drug: HL-085 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: Duration of the study, estimated to be approximately 24 months.
Dose limitation toxicities (DLT)
A DLT is defined as the occurrence of any of the following AE considered possibly, probably, or definitely related to the IP, HL-085, by the Investigator and/or the Sponsor that occurs during Cycle 1 as described in below:
- Any death not clearly due to the underlying disease or extraneous causes; or
- Non-hematologic toxicities Grade 3 or higher.
- Grade 3 thrombocytopenia with clinically significant bleeding, or other hematologic toxicity at Grade 4 or above.
- Neutropenic fever
- liver parameter abnormalities
- Any toxicity requiring permanent discontinuation of the IP
Measured: During Cycle 1 (the first 28 days)
Maximum tolerated dose (MTD)
MTD is defined as the highest dose level at which DLT occurs in less than 33.3% of subjects.
Measured: MTD will be determined when DLT occurs in great or equal to 33.3% of the same cohort subjects during During Cycle 1 (the first 28 days)
Secondary outcomes (2)
cMAX
cMAX is the maximum plasma concentration of HL-085 or metabolite(s).
Measured: Duration of the study, estimated to be approximately 24 months
Overall response rate (ORR)
ORR is the proportion of patients with a best overall response of complete response (CR) or partial response (PR), as assessed per response evaluation criteria in solid tumors (RECIST) v1.1.
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 posted5 Jun 2019
- Study start17 Jun 2019
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
Why it stopped: Study objective and design change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Kechow Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Liu, MD, PhD, Study director, KeChow Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976050
- Sponsor's protocol ID
- HL-085-US-101
- Status last verified
- Nov 2020
- First submitted
- 2 Jun 2019
- Last updated
- 18 Nov 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. 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 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03976050
- Acronym / sponsor ID
- HL-085-US-101
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study objective and design change
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Shanghai Kechow Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 5 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.
The study drug, HL-085 is a MEK inhibitor with the potential indication for cancers. It is an oral medication to be given daily.
The purposes of this study is to find answers to the following research questions:
- What is the highest tolerable dose of HL-085 that can be given to subjects when given orally (by mouth) on a twice daily basis?
- What are the side effects of HL-085?
- How much HL-085 is in the blood at specific times after dosing and how does the body get rid of the HL-085?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: HL-085Subjects in the dose escalation cohorts will receive ascending doses of HL-085 until the MTD is determined. The first three subjects will receive twice-daily doses (BID) of HL-085 6 mg. Additional cohorts may receive doses of HL-085 9, 12 or 18 mg BID respectively and sequentially. If DLTs are observed in <33.3% of subjects at the 18 mg dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have a pathologically documented solid tumor(s) that has relapsed from, or is refractory to standard treatment, or for which no standard treatment is available.
- Must have at least one measurable lesion as defined by RECISTv1.1 criteria for solid tumors.
- Must have received biological chemotherapy, immunotherapy or radiotherapy ≥4 weeks prior to starting the study treatment. Must have received small molecule chemotherapy ≥2 weeks or five half-lives (whichever is longer) prior to starting the study treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy ≥3 months (as judged by the Investigator).
Key exclusion criteria (21 listed)
- Have undergone or plan to have major surgery or experienced severe trauma ≤28 days prior to starting the study treatment.
- Known hypersensitivity to IP ingredients or their analogues.
- Prior therapy with a MEK-inhibitor
- Receipt of any other investigational agent therapy within 4 weeks prior to starting study treatment.
- Any concurrent therapy for cancer 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-085Also: No other interventionsHL-085 is a MEK inhibitor with potential indication for cancers. it will be given twice daily continuously in the study until disease progression; or the risks outweigh the benefits, if the subject continues study treatment; or subjects with poor compliance; or subjects need to receive or have already started alternative anti-tumor drugs; or Subjects who need to receive or have already started alternative any other concomitant medication and/or treatment, which would significantly impact their safety; or interruption of IP administration for more than 14 days due to IP-related AEs. | Drug | Dose escalation |
Primary outcome
Adverse events (AEs)
Time frame: Duration of the study, estimated to be approximately 24 months.
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Dose limitation toxicities (DLT)
Time frame: During Cycle 1 (the first 28 days)
A DLT is defined as the occurrence of any of the following AE considered possibly, probably, or definitely related to the IP, HL-085, by the Investigator and/or the Sponsor that occurs during Cycle 1 as described in below: * Any death not clearly due to the underlying disease or extraneous causes; or * Non-hematologic toxicities Grade 3 or higher. * Grade 3 thrombocytopenia with clinically significant bleeding, or other hematologic toxicity at Grade 4 or above. * Neutropenic fever * liver parameter abnormalities * Any toxicity requiring permanent discontinuation of the IP
Maximum tolerated dose (MTD)
Time frame: MTD will be determined when DLT occurs in great or equal to 33.3% of the same cohort subjects during During Cycle 1 (the first 28 days)
MTD is defined as the highest dose level at which DLT occurs in less than 33.3% of subjects.
2 secondary outcomes
cMAX
Time frame: Duration of the study, estimated to be approximately 24 months
Overall response rate (ORR)
Time frame: Duration of the study, estimated to be approximately 24 months
Results and safety
The study was stopped early (reason given: Study objective and design change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
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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.
Yi Liu, MD, PhD study director
KeChow Pharma
2 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 in people with Solid Tumor, Adult, run by Shanghai Kechow Pharma, Inc. at 2 sites in United States.
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 6 inclusion and 21 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: stopped early, as of the sponsor's last update on 18 Nov 2020. 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 United States. 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?
The study was stopped early (reason given: Study objective and design change). Results are not available in the source record.
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?
Adverse events (AEs) (time frame: Duration of the study, estimated to be approximately 24 months.). The study lists 3 primary outcomes in all. 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 18 Nov 2020.