NsclcPhase 1NCT03990077
Study of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC
A Phase 1 study testing HL-085 and Docetaxel in people with Nsclc, run by Shanghai Kechow Pharma, Inc. at 1 site in China.
Trial summary
This is a phase I, open label, dose escalation study to evaluate tolerability, safety , pharmacokinetics and efficacy in patients with KRAS mutant NSCLC by using HL-085 and Docetaxel. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nsclc
- What is being tested?
- HL-085 and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2020to 20 Jul 2021
- 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
- KRAS mutation NSCLC.
- 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
1 site in 1 country.
About this study
Official title: A Phase I , Single Arm, Dose Escalation Study to Evaluate Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC
This is a phase I, open label, dose escalation study to evaluate tolerability, safety , pharmacokinetics and efficacy in patients with KRAS mutant NSCLC by using HL-085 and Docetaxel.
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.
DocetaxelDrug
Docetaxel is an antineoplastic drug by inhibiting microtubule depolymerization, and attenuating of the effects of bcl-2 and bcl-xL gene expression.
| Study group | Role | What they receive |
|---|---|---|
| dose escalation of HL-085 plus Docetaxel | Experimental | HL-085 will be administered as BID with specified dose. And Docetaxel will be taken as the instruction in the label ( 75mg/m2，IV).
f 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. Receives: Drug: HL-085; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs)
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.
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 more than 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 (3)
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
Peak Plasma Concentration (Cmax)
Cmax is the maximum plasma concentration of HL-085 or metabolite(s).
Measured: Duration of the study, estimated to be approximately 24 months
Area under the plasma concentration verus time curve(AUC)
AUC of HL-085 or metabolites(s) after 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 posted18 Jun 2019
- Study start21 May 2020
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Why it stopped: drug development strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NsclcStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Kechow Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongqi Tian, PhD, Study director, Shanghai Kechow Pharma.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990077
- Sponsor's protocol ID
- HL-085-103
- Status last verified
- Dec 2020
- First submitted
- 12 Jun 2019
- Last updated
- 10 Dec 2021
- Results posted
- 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 10 Dec 2021. 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 Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 Plus Docetaxel in Patients With KRAS Mutant NSCLC
- ClinicalTrials.gov ID
- NCT03990077
- Acronym / sponsor ID
- HL-085-103
- Conditions
- Nsclc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: drug development strategy adjustment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Shanghai Kechow Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 May 2020 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 18 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, open label, dose escalation study to evaluate tolerability, safety , pharmacokinetics and efficacy in patients with KRAS mutant NSCLC by using HL-085 and Docetaxel.
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 |
|---|---|---|
| dose escalation of HL-085 plus Docetaxel | Experimental | Drug: HL-085, Drug: DocetaxelHL-085 will be administered as BID with specified dose. And Docetaxel will be taken as the instruction in the label ( 75mg/m2，IV). f 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- KRAS mutation NSCLC.
- 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 | dose escalation of HL-085 plus Docetaxel |
| DocetaxelDocetaxel is an antineoplastic drug by inhibiting microtubule depolymerization, and attenuating of the effects of bcl-2 and bcl-xL gene expression. | Drug | dose escalation of HL-085 plus Docetaxel |
Primary outcome
Number of Adverse Events (AEs)
Time frame: Duration of the study, estimated to be approximately 24 months
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.
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 more than 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity (DLT)
3 secondary outcomes
Overall response rate (ORR)
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
Area under the plasma concentration verus time curve(AUC)
Time frame: Duration of the study, estimated to be approximately 24 months
Results and safety
The study was stopped early (reason given: drug development strategy adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- 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, PhD study director
Shanghai Kechow Pharma.
1 site 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 Docetaxel in people with Nsclc, 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 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: stopped early, as of the sponsor's last update on 10 Dec 2021. 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 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: drug development strategy adjustment). 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?
Number of Adverse Events (AEs) (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?
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 10 Dec 2021.