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Closed (no longer recruiting)Last updated: 1 February 2024

This phase I trial is evaluating the effectiveness, safety and tolerance for a targeted therapy (XNW7201) to treat patients with locally advanced or metastatic solid tumours.A phrase I, open-label, multi-center, non-randomized, dose escalation study to evaluate the safety, tolerability and pharmacokinetic profile of XNW7201 in subjects with advanced solid tumours

Clinical summary

Summary

Patients eligible to participate in this trial will receive a specified dose of XNW7201.

Conditions

This trial is treating patients with Solid tumours.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Sinovent Pty Ltd

Scientific Title

A phrase I, open-label, multi-center, non-randomized, dose escalation study to evaluate the safety, tolerability and pharmacokinetic profile of XNW7201 in subjects with advanced solid tumours

Eligibility

Inclusion

  • 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);

Exclusion

  • 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.

Inclusion

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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