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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03901950




Registration number
NCT03901950
Ethics application status
Date submitted
2/04/2019
Date registered
3/04/2019
Date last updated
30/12/2019

Titles & IDs
Public title
Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of XNW7201 in Subjects With Advanced Solid Tumors
Scientific title
A Phrase I, Open-label, Multi-center, Non-randomized, Does Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of XNW7201 in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
XNW7201-1-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XNW7201 tablets

Experimental: XNW7201 -


Treatment: Drugs: XNW7201 tablets
A wnt pathway inhibitor

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

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of XNW7201 tablets in subjects with advanced solid tumor; - Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Timepoint [1] 0 0
From date of first dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to about 6 months
Primary outcome [2] 0 0
The dose-limiting toxicity (DLT) of XNW7201 - Dose-limiting toxicity (DLT) is defined as the adverse events these Grade =3 related to XNW7201 treatment that occur from single dose to the last day of Cycle 1 in multiple doses in the dose escalation stage (CTCAE, V5.0).
Timepoint [2] 0 0
At the end of Cycle 1 (each cycle is 30 days)

Eligibility
Key inclusion criteria
- 1. Subjects who are voluntary to participate in this clinical study, able to
understand the study procedure and have signed the informed consent form;

2. Male or female subjects =18 years of age;

3. Subjects with histologically or cytologically confirmed advanced solid tumors after
failure of standard of care, or intolerability to standard of care, or with no
standard of care;

4. ECOG Performance Status of 0 or 1 at both the screening and baseline visits;

5. Life expectancy =12 weeks;

6. Subjects with at least one measurable lesion in accordance with RECIST 1.1(not
required for dose escalation part);

7. Adequate laboratory parameters during screening as evidenced by:

- Adequate bone marrow reserve: absolute neutrophil count (ANC) =1.5×109/L,
platelet count =100×109/L and hemoglobin =90 g/dL;

- Basically normal liver function: total bilirubin = 1.5 × upper limit of normal
(ULN); ALT and AST=2.5 × ULN or = 5 × ULN when metastases to liver occurs;

- Normal renal function: serum creatinine level>1.5 × ULN or endogenous creatinine
clearance <60 mL/min (using Cockcroft-Gault formula);

- Basically normal coagulation: prothrombin time (PT), international normalized
ratio (INR) and activated partial thromboplastin time (APTT) = 1.5 × ULN;

- Cardiac function: left ventricular ejection fraction (LVEF) =50%; basically
normal ECG, QTcF interval=70 ms (QTc interval corrected by Fridericia's
Correction Formula);
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 1. Known or suspected history of allergy to XNW7201 tablet and its metabolite or its
excipients;

2. Subjects who previously received treatment with WNT inhibitor;

3. Subjects with one of the various factors affecting absorption of oral drugs (e.g.,
inability to swallow, chronic diarrhoea and intestinal obstruction) or active
gastrointestinal disorder, gastric bypass or other diseases that could significantly
affect drug absorption, distribution, metabolism or excretion;

4. Presence of CTCAE Grade > 1 adverse events induced by previous treatment that is
still not relieved prior to the first dose, not including alopecia and tolerable
adverse event as judged by investigators;

5. Participation in other clinical studies within 4 weeks prior to the first dose of
XNW7201;

6. Any chemotherapy, biotherapy, radiotherapy, hormone therapy, targeted anti-tumor
therapy (excluding nitrosourea and mitomycin C) administered within 4 weeks before the
first dose of the investigational drug); nitrosourea or mitomycin C administered
within 6 weeks before the first dose of the investigational drug;

7. Major surgery or active ulcer or incomplete healing of wound within 4 weeks prior
to the first dose;

8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, severe active peptic ulcer disease or gastritis,
or psychiatric illness/social situations that would limit compliance with study
requirement or compromise the ability of the subject to give written informed consent;

9. Any unstable, pre-existing major medical condition that in the opinion of the
investigator contraindicates the use of the investigational drug, including known
human immunodeficiency (HIV) or active hepatitis B virus (HBV) or hepatitis C virus
(HCV) infection;

10. Women who are pregnant or breastfeeding.

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)
QLD
Recruitment hospital [1] 0 0
Integrated Clinical Oncology network Pty Ltd - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane

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

Ethics approval
Ethics application status

Summary
Brief summary
The research project is testing this potential new medication for advanced solid tumours.
This research project is being done to get more information about the study drug (XNW7201).
The study drug is a potential new medication that blocks the activity of a protein found in
cancer cells called Wnt. Studies have shown that, in cancer, Wnt is involved in the
uncontrolled growth of cancer cells and helping them survive. It is hoped that by blocking
the activity of Wnt, the study drug may decrease the growth of cancer cells and their
survival. The purpose of this research is to check that the study drug is safe and to see how
well it is tolerated in participants with locally advanced or metastatic solid tumours.
Another purpose is to find out the highest dose that is well tolerated (called the maximum
tolerated dose) and the right dose to use in future clinical research studies with this
potential new medication.
Trial website
https://clinicaltrials.gov/show/NCT03901950
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
Ying Zhang
Address 0 0
Country 0 0
Phone 0 0
+862161268794
Fax 0 0
Email 0 0
ying.zhang@sinovent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03901950