COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04122339




Registration number
NCT04122339
Ethics application status
Date submitted
29/09/2019
Date registered
10/10/2019
Date last updated
26/05/2020

Titles & IDs
Public title
MAX-10181 Given Orally to Patients With Advanced Solid Tumor
Scientific title
A Phase I Study of MAX-10181 Given Orally to Patients With Advanced Solid Tumor
Secondary ID [1] 0 0
Maxinovel-10181-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MAX-10181

Experimental: MAX-10181 - tablet


Treatment: Drugs: MAX-10181
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events (AEs) - Incidence of treatment-related AEs
Timepoint [1] 0 0
8 weeks
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
4 weeks
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
4 weeks
Secondary outcome [1] 0 0
Tmax - Time to maximum plasma concentration
Timepoint [1] 0 0
Approximately 4 weeks
Secondary outcome [2] 0 0
Cmax - Time to maximum plasma concentration
Timepoint [2] 0 0
Approximately 4 weeks
Secondary outcome [3] 0 0
AUC - Area under the time-concentration curve
Timepoint [3] 0 0
Approximately 4 weeks
Secondary outcome [4] 0 0
t1/2 - Observed terminal half-life
Timepoint [4] 0 0
Approximately 4 weeks
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
12 months (anticipated)

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Maxinovel Pty., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT04122339
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Hanying bao, MD,Ph.D
Address 0 0
Country 0 0
Phone 0 0
+86-021-51370693
Fax 0 0
Email 0 0
hybao@maxinovel.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04122339