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Advanced Solid TumorsPhase 1NCT03901950

Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of XNW7201 in Subjects With Advanced Solid Tumors

A Phase 1 study testing XNW7201 tablets in people with Advanced Solid Tumors, run by Evopoint Biosciences Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
XNW7201 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteAustralia
Study dates
1 Jul 2019to 30 Jun 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

  • 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);
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  • 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);

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Integrated Clinical Oncology network Pty Ltd

    South Brisbane, Queensland, 4101

Other trials in Australia

About this study

Official 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

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.

Being tested
XNW7201 tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XNW7201 tabletsDrug

    A wnt pathway inhibitor

Study groups in NCT03901950
Study groupRoleWhat they receive
XNW7201ExperimentalNot described
Receives: Drug: XNW7201 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

  2. 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).

    Measured: At the end of Cycle 1 (each cycle is 30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2019
  2. Study start1 Jul 2019
  3. Primary completion30 Dec 2021
  4. Study completion30 Jun 2022

Resources

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
Model description
There will be 5 different doses of the study drug that will be tested. The dose of study drug that you will take will depend on when you enter the research project. The first few participants who enter the research project early will take lower doses of the study drug. Participants entering the research project at a later time will take higher doses of the study drug only if the lower doses that have been tested are well tolerated. You will be closely monitored after you take the study drug.
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03901950
Sponsor's protocol ID
XNW7201-1-02
Status last verified
Feb 2023
First submitted
2 Apr 2019
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XNW7201 tablets in people with Advanced Solid Tumors, run by Evopoint Biosciences Inc. 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 12 inclusion and 10 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 16 Feb 2023. 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?

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?

Safety and tolerability of XNW7201 tablets in subjects with advanced solid tumor; (time frame: 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). 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?

On the ClinicalTrials.gov record for NCT03901950.

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 16 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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