Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of XNW7201 in Subjects With Advanced Solid Tumors
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Queensland
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South Brisbane, Queensland, Australia, 4101
- Integrated Clinical Oncology Network Pty Ltd
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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);
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: XNW7201
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A wnt pathway inhibitor
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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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 dose-limiting toxicity (DLT) of XNW7201
Time Frame: At the end of Cycle 1 (each cycle is 30 days)
|
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).
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At the end of Cycle 1 (each cycle is 30 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jason Le, Evopoint Biosciences Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XNW7201-1-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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