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Phase 1 Lung Cancer Trial, Not Yet Recruiting
NCT07538973
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are able to give signed consent before taking part and who fully understand what the trial involves, including its procedures and possible side effects.
- People who are male or female and aged between 18 and 65 years (inclusive).
- People who weigh at least 50 kg (if male) or at least 45 kg (if female), and whose Body Mass Index (BMI — a measure of body weight relative to height) falls between 18 and 30 kg/m² (inclusive).
- People (and their partners) who agree to use effective contraception from the screening stage until 6 months after the last dose of the study drug.
- People who are able to communicate well with the research team and can follow the study procedures as required.
- For people with normal liver function: those who test negative for Hepatitis B surface antigen and Hepatitis C antibody.
- For people with normal liver function: those whose liver function test results are normal, or show only minor abnormalities that are not considered medically significant.
- For people with normal liver function: those who are matched to the liver impairment group in terms of sex ratio (within 1 person per gender), average age (within 10 years), and average body weight (within 10 kg).
- For people with liver impairment: those who have a history of, or have been diagnosed at screening with, a primary liver disease — this may include but is not limited to Hepatitis B, Hepatitis C, non-alcoholic fatty liver disease, or alcoholic liver disease.
- For people with liver impairment: those whose liver impairment is caused by a previously diagnosed primary liver disease (diagnosed at least 2 weeks before screening, and not cancer-related), and is classified as Child-Pugh Class A or B — a medical rating system for liver disease severity (confirm with trial site).
- For people with liver impairment: those whose liver function has been stable for at least 2 weeks before taking the study drug, as assessed by the investigator.
- For people with liver impairment: those who have not taken any liver disease medication in the 4 weeks before screening, or who have been on a stable medication routine for their existing liver condition.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have a serious disease affecting a major organ — such as the digestive system, lungs, kidneys, nervous system, blood, hormones, immune system, mental health, or heart — if the investigator considers this makes participation unsuitable (this does not apply to liver impairment patients regarding their liver disease and related complications).
- People whose physical examination, vital signs, or lab test results (including blood, urine, or clotting tests) show abnormalities considered clinically significant by the investigator, making participation unsuitable (this does not apply to liver impairment patients regarding their liver disease and related complications).
- People who have taken part in another clinical drug trial or used an investigational drug within the 3 months before screening.
- People who test positive for HIV or syphilis at screening.
- People who have conditions that could affect how the study drug is absorbed, processed, or removed by the body (for example, difficulty swallowing), or who have had part of their digestive tract surgically removed in a way that could affect this.
- People who have clinically significant abnormalities on an electrocardiogram (ECG — a heart tracing test), such as a heart rate that is too fast or too slow and requires medication, certain types of heart rhythm problems, or other ECG findings the investigator considers unsuitable.
- People who have used certain medications that affect how the body processes drugs (specifically CYP3A4 inhibitors such as clarithromycin, itraconazole, or lopinavir, or CYP3A4 inducers such as rifampicin, carbamazepine, or phenytoin) within 4 weeks before screening (confirm with trial site if unsure about specific medications).
- People who have used any prescription medicines, over-the-counter medicines, herbal remedies, or dietary supplements (such as vitamins or calcium) within 2 weeks before screening — except for liver impairment patients using medications to manage their liver condition and related complications.
- People who have a known allergy to any ingredient in TQ-B3101 capsules, or who have a history of being prone to allergic reactions such as drug allergy, rashes, eczema, hives, or asthma.
- People who have smoked more than an average of 5 cigarettes per day in the 3 months before screening.
- People who have a history of drug abuse in the 3 months before screening, or who test positive on a urine drug screening test.
- People with alcoholic liver disease who have a history of heavy alcohol use in the 12 months before screening; for all other participants, those with a history of heavy alcohol use in the 3 months before screening (defined as drinking more than an average of 2 units of alcohol per day, where 1 unit equals 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine).
- People who have donated blood or plasma, lost 200 mL or more of blood, or undergone a plasma removal procedure within 4 weeks before screening.
- People who have consumed alcohol, grapefruit juice, pomelo juice, coffee, tea, cola, or chocolate within 1 week before taking the study drug — or who test positive on a breath alcohol test the day before dosing; for people with alcoholic liver disease, those who have consumed any alcohol-containing products within 2 weeks before dosing.
- People whose kidney filtering ability (creatinine clearance) is measured at less than 60 mL/min using a standard calculation method.
- Female participants who are breastfeeding, or who test positive for pregnancy during screening or at any point during the trial.
- People who the investigator considers unsuitable for any other reason.
- For people with liver impairment: those who have previously had a liver transplant.
- For people with liver impairment: those who have experienced a period of confusion or altered mental function related to liver disease (hepatic encephalopathy) within 30 days before screening.
- For people with liver impairment: those who have used any medication considered capable of causing sudden liver damage (such as halothane or methotrexate) within 3 months before screening.
- For people with liver impairment: those who have had drug- or virus-caused sudden liver inflammation (acute hepatitis) within 2 months before screening.
- For people with liver impairment: those who have had a rapid worsening of their liver condition, or a significant rise in certain liver enzyme levels in blood tests (ALT/AST rising to more than 3 times the upper limit of normal), within 2 weeks before taking the study drug, as judged by the investigator.
- For people with liver impairment: those who have experienced a worsening of liver-related confusion or altered mental function (hepatic encephalopathy) within 30 days before taking the study drug.
- For people with liver impairment: those who have conditions affecting how bile is processed or removed from the body, such as biliary cirrhosis, blockage of the liver or bile ducts, or cholestatic liver disease.
- For people with liver impairment: those who have liver failure or related complications that the investigator considers unsuitable for participation — such as liver-related confusion, liver cancer, bleeding from veins in the food pipe or stomach within the past 3 months, severe high blood pressure in the liver's blood vessels, or a history of surgery to redirect blood flow around the liver.
- For people with liver impairment: those who are taking other medications that the investigator judges may interfere with measuring how the body processes the study drug TQ-B3101 and its breakdown products.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Phone: 18661809090
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 April 2026
Est. completion
1 March 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
To determine the Cmax; To determine the Area Under the Curve (AUC) 0-t; To determine the AUC 0-∞
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.