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New treatment option for Advanced Solid Tumor
Official title A Study of XZB-0004 in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT05772455
What this study is testing
What is XZB-0004?
XZB-0004 is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- XZB-0004 is a novel and potent small molecule inhibitor of receptor tyrosine kinase AXL. This is an open-label, multicentre phase I study of XZB-0004 in patients with solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patient has signed informed consent before any trial related activities.
- Be 18 years of age or older and less than 75 years at the time of signing the informed consent.
- Part 1: Have a histologically or cytologically confirmed diagnosis of a solid tumour malignancy; Part 2：Have a histologically or cytologically...
- Have evaluable (for Part 1) or measurable (for Part 2) disease as the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
- Have a performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
You likely can't join if
- Previous use of AXL inhibitors and immunotherapy was consistent with protocol requirements.
- Received anti-tumor therapy such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy or other therapy within 4 weeks prior to...
- Received other unmarketed investigational drugs or treatments within 4 weeks or 5 times the elimination half-life prior to the first dose of the...
- Treatment with systemic glucocorticoids (prednisone \> 10mg per day or equivalent) or other immunosuppressive agents within 14 days before the first...
- Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug.
- Patient with heart function impaired or clinically significant heart disease.
See the full eligibility criteria
- Patient has signed informed consent before any trial related activities.
- Be 18 years of age or older and less than 75 years at the time of signing the informed consent.
- Part 1: Have a histologically or cytologically confirmed diagnosis of a solid tumour malignancy; Part 2：Have a histologically or cytologically confirmed diagnosis of a NSCLC or solid tumour malignancy.
- Have evaluable (for Part 1) or measurable (for Part 2) disease as the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
- Have a performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- Have adequate organ function.
- Have recovered to ≤ grade 1 or Meet the requirements of the study from the effects of any prior cancer therapy, except for alopecia; irreversible neuropathy should have recovered to ≤ grade 2.
- Have a life expectancy greater than 3 months.
- Eligible patients (male and female) who are fertile must agree to at least use a reliable contraceptive method with partner.
- Willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Previous use of AXL inhibitors and immunotherapy was consistent with protocol requirements.
- Received anti-tumor therapy such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy or other therapy within 4 weeks prior to the first dose of the investigational drug.
- Received other unmarketed investigational drugs or treatments within 4 weeks or 5 times the elimination half-life prior to the first dose of the investigational drug.
- Treatment with systemic glucocorticoids (prednisone \> 10mg per day or equivalent) or other immunosuppressive agents within 14 days before the first dose of a trial drug.
- Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug.
- Patient with heart function impaired or clinically significant heart disease.
- Any condition or illness that, in the opinion of the Investigator, would interfere with the evaluation of the safety of the study drug.
- History of immune deficiencies, including positive HIV antibody tests.
- Patient is in the active stage of HBV or HCV.
- History of solid organ transplant or bone marrow transplant.
- Any other malignant tumor has been diagnosed within 5 years.
- Has known Primary tumor of the central nervous system or central nervous system metastase.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage were present within 4 weeks before the first dose of the trial drug.
- people with psychiatric disorders that may affect trial compliance.
- history of Alcoholism or drug abuse.
- Pregnant or breastfeeding.
- The researchers considered that there were some cases that were not suitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.