Actively Recruiting
A Study of XZB-0004 in Patients With Solid Tumors
Led by Xuanzhu Biopharmaceutical Co., Ltd. · Updated on 2024-10-28
128
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Part 1 is a dose-escalation study to evaluate the safety, pharmacokinetic (PK), and pharmacodynamic profile of XZB-0004, and then to identify a safe and pharmacologically active dose for evaluation in subsequent cohorts or clinical studies. Part 2 is a study to evaluate the efficacy and safety of XZB-0004 combined with Penpulimab in patients with NSCLC or advanced solid tumors.
CONDITIONS
Official Title
A Study of XZB-0004 in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 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 64 grade 1 or meet the study requirements from effects of prior cancer therapy, except alopecia; irreversible neuropathy should have recovered to 64 grade 2.
- Have a life expectancy greater than 3 months.
- Eligible patients who are fertile must agree to use a reliable contraceptive method with their partner.
- Willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
You will not qualify if you...
- Previous use of AXL inhibitors and immunotherapy inconsistent 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.
- Received unmarketed investigational drugs or treatments within 4 weeks or 5 times the elimination half-life before the first dose.
- Treatment with systemic glucocorticoids (prednisone > 10mg per day or equivalent) or other immunosuppressive agents within 14 days before the first dose.
- Inability to swallow, intestinal obstruction, or other factors affecting drug absorption.
- Patient with impaired heart function or clinically significant heart disease.
- Any condition or illness that would interfere with safety evaluation.
- History of immune deficiencies, including positive HIV antibody tests.
- Patient is in the active stage of HBV or HCV.
- History of solid organ or bone marrow transplant.
- Any other malignant tumor diagnosed within 5 years.
- Known primary tumor of the central nervous system or CNS metastases.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage within 4 weeks before dosing.
- Psychiatric disorders that may affect trial compliance.
- History of alcoholism or drug abuse.
- Pregnant or breastfeeding.
- Cases deemed unsuitable for inclusion by researchers.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
X
Xiujie Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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