Solid TumorPhase 1NCT04122339
MAX-10181 Given Orally to Patients With Advanced Solid Tumor
A Phase 1 study testing MAX-10181 in people with Solid Tumor, run by Maxinovel Pty., Ltd. at 1 site in Australia.
Trial summary
This is a multi-center, first-in-human, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- MAX-10181
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Feb 2020to 1 Nov 2022
- 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
- Males and/or females over age 18.
- Histologically or cytologically confirmed advanced or metastatic solid tumor for which no established standard therapy is available.
- At least one measurable lesion by CT or MRI according to RECIST1.1, which is not in irradiated area (only for expansion phase).
- Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (in case of alopecia, Grade 2 is acceptable).
- Life expectancy of at least 3 months.
- Female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly.
Who cannot join
- Laboratory values not within the Protocol-defined range.
- 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.
- Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry.
- 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.
- Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
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- Anti-cancer treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), hormone therapy, or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
- Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis.
- History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation.
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 6009
Michael Millward, MD,PhD, +61 8 8361 3222, hybao@maxinovel.com
About this study
Official title: A Phase I Study of MAX-10181 Given Orally to Patients With Advanced Solid Tumor
This is a multi-center, first-in-human, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumor.
- Conditions
- Solid Tumor
- Being tested
- MAX-10181
- Keywords
- PD-1/L1, immunotherapy, advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAX-10181Drug
Part 1: Dose escalation, MAX-10181 once or twice daily with dose modifications based on tolerability criteria.
Part 2: Dose expansion, Recommended doses from Part 1.
| Study group | Role | What they receive |
|---|---|---|
| MAX-10181 | Experimental | tablet Receives: Drug: MAX-10181 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence of treatment-related AEs
Measured: 8 weeks
Maximum tolerated dose (MTD）
MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
Measured: 4 weeks
Phase II dose (RP2D)
The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of MAX-10181.
Measured: 4 weeks
Secondary outcomes (5)
Tmax
Time to maximum plasma concentration
Measured: Approximately 4 weeks
Cmax
Time to maximum plasma concentration
Measured: Approximately 4 weeks
AUC
Area under the time-concentration curve
Measured: Approximately 4 weeks
t1/2
Observed terminal half-life
Measured: Approximately 4 weeks
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Measured: 12 months (anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start11 Feb 2020
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxinovel Pty., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122339
- Sponsor's protocol ID
- Maxinovel-10181-001
- Status last verified
- Jan 2022
- First submitted
- 29 Sep 2019
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of MAX-10181 Given Orally to Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT04122339
- Acronym / sponsor ID
- Maxinovel-10181-001
- Conditions
- Solid Tumor
- Keywords
- PD-1/L1, immunotherapy, advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maxinovel Pty., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 10 Oct 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 multi-center, first-in-human, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAX-10181 | Experimental | Drug: MAX-10181tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and/or females over age 18.
- Histologically or cytologically confirmed advanced or metastatic solid tumor for which no established standard therapy is available.
- At least one measurable lesion by CT or MRI according to RECIST1.1, which is not in irradiated area (only for expansion phase).
- Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (in case of alopecia, Grade 2 is acceptable).
- Life expectancy of at least 3 months.
Key exclusion criteria (11 listed)
- Laboratory values not within the Protocol-defined range.
- 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.
- Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry.
- 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.
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 |
|---|---|---|
| MAX-10181Part 1: Dose escalation, MAX-10181 once or twice daily with dose modifications based on tolerability criteria. Part 2: Dose expansion, Recommended doses from Part 1. | Drug | MAX-10181 |
Primary outcome
Adverse events (AEs)
Time frame: 8 weeks
Incidence of treatment-related AEs
Maximum tolerated dose (MTD）
Time frame: 4 weeks
MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
Phase II dose (RP2D)
Time frame: 4 weeks
The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of MAX-10181.
5 secondary outcomes
Tmax
Time frame: Approximately 4 weeks
Cmax
Time frame: Approximately 4 weeks
AUC
Time frame: Approximately 4 weeks
t1/2
Time frame: Approximately 4 weeks
Objective response rate (ORR)
Time frame: 12 months (anticipated)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 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.
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 MAX-10181 in people with Solid Tumor, run by Maxinovel Pty., Ltd. at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanying bao, MD,Ph.D (+86-021-51370693, hybao@maxinovel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: 8 weeks). 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 19 Jan 2022.