A Study of XZB-0004 in Patients With Solid Tumors

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor, NSCLC

In brief

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.

Key facts

Study ID

NCT05772455

Run by

Xuanzhu Biopharmaceutical Co., Ltd.

People needed

128

Starts

2023-03-24

Expected to finish

2027-02-01

Last updated by the study team

2024-10-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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.

You may not qualify 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 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.
• Subjects 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.

Where it is running

• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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