NeoplasmPhase 1NCT02759640
A Phase I Trial of HS-10241 in Solid Tumors
A Phase 1 study testing HS-10241 in people with Neoplasm and Solid Tumors, run by Atridia Pty Ltd. at 2 sites in Australia.
Trial summary
This is a phase 1, open-label, dose-escalation trial of HS-10241 as monotherapy in subjects with solid tumors. HS-10241 will be administered orally once daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm, Solid Tumors
- What is being tested?
- HS-10241
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesAustralia
- Study dates
- Sep 2016to May 2018
- 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
- At least 18 years of age
- Ability to understand the purposes and risks of the trial and his/her informed consent using the Human Research Ethics Committee (HREC) approved informed consent form (ICF).
- Histologically or cytologically confirmed advanced or metastatic solid tumor for which standard therapy does not exist, has failed, or has been refused.
- Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (except alopecia)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
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- Acceptable liver function defined below:
- Total bilirubin ≤ 2 times upper limit of normal range (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN; however, ≤5 times ULN in a subject who has liver metastases
- Acceptable renal function defined below:
- Serum creatinine ≤1.5 times ULN or calculated creatinine clearance (by the Cockcroft-Gault formula) ≥60 mL/minutes
- Acceptable coagulation status defined below:
- Prothrombin time <1.5 times ULN
- Partial thrombin time <1.5 times ULN
- Acceptable hematologic status (without hematologic supports including hematopoietic factor, blood transfusion) defined below:
- Absolute neutrophil count (ANC) ≥1500/μL
- Platelet count ≥100000/μL
- Hemoglobin ≥9.0 g/dL
- No clinically significant abnormalities in urinalysis
- All participants must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an intrauterine device) with their partner from entry into the trial through 6 months after the last dose.
Who cannot join
- Hematologic malignancies
- Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery
- Percutaneous coronary intervention conducted within 6 months prior to the trial entry for cardiac infarction or angina pectoris
- Seizure disorders requiring anticonvulsant therapy
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- Taking a medication that prolongs QT interval and has a risk of Torsade de Pointes, or a history of long QT syndrome
- Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product
- Anti-cancer treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry. Ongoing androgen deprivation therapy or bisphosphonates are allowed.
- Participation in an investigational drug or device trial within 4 weeks prior to the trial entry
- Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Recent venous thrombosis (including deep vein thrombosis or pulmonary embolism within 1 year of trial entry)
- History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis;
- Subject is pregnant (positive serum beta human chorionic gonadotropin [β-HCG] test at Screening) or is currently breast-feeding, their partner anticipates becoming pregnant/impregnating during the trial or within 6 months after receiving the last dose of trial treatment
- Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial
- History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation
- Unwillingness or inability to comply with the trial protocol for any reason
- Legal incapacity or limited legal capacity
- Known drug abuse or alcohol abuse
- Taking a medication that is a moderate or strong inhibitor or inducer of CYP2C9. Patients are eligible if these medications can be stopped or substituted within the screening period.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Liverpool
Liverpool, New South Wales, 2170
About this study
Official title: First-in-Human, Dose-Escalation Trial of C-Met Kinase Inhibitor HS-10241 in Subjects With Advanced Solid Tumors
This is a phase 1, open-label, dose-escalation trial of HS-10241 as monotherapy in subjects with solid tumors. HS-10241 will be administered orally once daily.
Read the detailed description
Recently, c-Met has become an important target of intensive research in search of specific inhibitors as potential new therapies for cancers driven by c-Met activation. HS-10241 is a potent and selective small molecule c-Met kinase inhibitor for both enzyme and c-Met phosphorylation in the cell. Consistent with its potent enzyme and cell activity, HS-10241 was found to inhibit cell growth in vitro against tumors with c-Met gene amplification or c-Met overexpression. On the basis of these findings, the current trial will be conducted in participants with advanced solid tumors for whom standard treatment is not currently available.
This study consists of 2 phases. In the dose-escalation phase, up to 5 dose levels of HS-10241 (100 mg/day, 200 mg/day, 340 mg/day, 500 mg/day, and 700 mg/day) will be investigated with a sequential "3+3" design (3 or 6 participants in every dose level). Participants will have a single-dose pharmacokinetic (PK) run-in period (7 days). Following the first dose, participants will enter a 1 week treatment-free period to evaluate safety and single-dose PK. If no dose-limiting toxicities (DLTs) are observed during the 1-week period, HS-10241 administration will resume at the same dose level.
In the expansion phase, up to 12 additional participants will be enrolled at the MTD. Anti-tumor effects will be assessed every 2 cycles (4 weeks=1 cycle) by using RECIST version 1.1 criteria.
- Conditions
- Neoplasm, Solid Tumors
- Being tested
- HS-10241
- Keywords
- c-Met kinase inhibitor, Advanced solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10241Drug
HS-10241 is administered orally starting at 100 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| HS-10241 | Experimental | HS-10241 is administered orally starting at 100 mg/day. Receives: Drug: HS-10241 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
MTD is defined as the maximum dose level at which no more than 1 out of 3 participants experience a DLT within the first 4 weeks of multiple dosing.
Measured: 4 weeks
Secondary outcomes (8)
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: 24 months
Peak plasma concentration (Cmax)
Measured: 4 weeks
Area under the plasma concentration-time curve (AUC）
Measured: 4 weeks
T1/2 (half-life)
Measured: 4 weeks
Objective response rate (ORR)
Measured: 24 months
Time to reach maximum plasma concentration (Tmax)
Measured: 4 weeks
Clearance (CL)
Measured: 4 weeks
Volume of distribution at steady state (Vss)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759640
- Sponsor's protocol ID
- HS-10241-001
- Status last verified
- Feb 2019
- First submitted
- 29 Apr 2016
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human, Dose-Escalation Trial of C-Met Kinase Inhibitor HS-10241 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02759640
- Acronym / sponsor ID
- HS-10241-001
- Conditions
- Neoplasm, Solid Tumors
- Keywords
- c-Met kinase inhibitor, Advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 3 May 2016 (estimated)
- 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 1, open-label, dose-escalation trial of HS-10241 as monotherapy in subjects with solid tumors. HS-10241 will be administered orally once daily.
Detailed description
Recently, c-Met has become an important target of intensive research in search of specific inhibitors as potential new therapies for cancers driven by c-Met activation. HS-10241 is a potent and selective small molecule c-Met kinase inhibitor for both enzyme and c-Met phosphorylation in the cell. Consistent with its potent enzyme and cell activity, HS-10241 was found to inhibit cell growth in vitro against tumors with c-Met gene amplification or c-Met overexpression. On the basis of these findings, the current trial will be conducted in participants with advanced solid tumors for whom standard treatment is not currently available.
This study consists of 2 phases. In the dose-escalation phase, up to 5 dose levels of HS-10241 (100 mg/day, 200 mg/day, 340 mg/day, 500 mg/day, and 700 mg/day) will be investigated with a sequential "3+3" design (3 or 6 participants in every dose level). Participants will have a single-dose pharmacokinetic (PK) run-in period (7 days). Following the first dose, participants will enter a 1 week treatment-free period to evaluate safety and single-dose PK. If no dose-limiting toxicities (DLTs) are observed during the 1-week period, HS-10241 administration will resume at the same dose level.
In the expansion phase, up to 12 additional participants will be enrolled at the MTD. Anti-tumor effects will be assessed every 2 cycles (4 weeks=1 cycle) by using RECIST version 1.1 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-10241 | Experimental | Drug: HS-10241HS-10241 is administered orally starting at 100 mg/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- At least 18 years of age
- Ability to understand the purposes and risks of the trial and his/her informed consent using the Human Research Ethics Committee (HREC) approved informed consent form (ICF).
- Histologically or cytologically confirmed advanced or metastatic solid tumor for which standard therapy does not exist, has failed, or has been refused.
- Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (except alopecia)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (20 listed)
- Hematologic malignancies
- Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery
- Percutaneous coronary intervention conducted within 6 months prior to the trial entry for cardiac infarction or angina pectoris
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 |
|---|---|---|
| HS-10241HS-10241 is administered orally starting at 100 mg/day. | Drug | HS-10241 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 4 weeks
MTD is defined as the maximum dose level at which no more than 1 out of 3 participants experience a DLT within the first 4 weeks of multiple dosing.
8 secondary outcomes
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: 24 months
Peak plasma concentration (Cmax)
Time frame: 4 weeks
Area under the plasma concentration-time curve (AUC）
Time frame: 4 weeks
T1/2 (half-life)
Time frame: 4 weeks
Objective response rate (ORR)
Time frame: 24 months
Time to reach maximum plasma concentration (Tmax)
Time frame: 4 weeks
Clearance (CL)
Time frame: 4 weeks
Volume of distribution at steady state (Vss)
Time frame: 4 weeks
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 20 Jul 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HS-10241 in people with Neoplasm and Solid Tumors, run by Atridia Pty Ltd. at 2 sites in Australia.
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 20 inclusion and 20 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 20 Jul 2022. 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 Australia. 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 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?
Maximum tolerated dose (MTD) (time frame: 4 weeks). 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 20 Jul 2022.