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A Study of XZB-0004 in Patients With Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study of XZB-0004 in Patients With Solid Tumors

A Phase I, Open-label, Dose-escalation Study of the Safety, Pharmacokinetics and Efficacy of the XZB-0004 in Patients With Solid Tumours

NCT05772455•Xuanzhu Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient has signed informed consent before any trial related activities.
•2. Be 18 years of age or older and less than 75 years at the time of signing the informed consent.
•3. 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.
•4. Have evaluable (for Part 1) or measurable (for Part 2) disease as the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
•5. Have a performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
•6. Have adequate organ function.
•7. 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.
•8. Have a life expectancy greater than 3 months.
•9. Eligible patients (male and female) who are fertile must agree to at least use a reliable contraceptive method with partner.
•10. Willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria

•1. Previous use of AXL inhibitors and immunotherapy was consistent with protocol requirements.
•2. 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.
•3. 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.
•4. 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.
•5. Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug.
•6. Patient with heart function impaired or clinically significant heart disease.
•7. Any condition or illness that, in the opinion of the Investigator, would interfere with the evaluation of the safety of the study drug.
•8. History of immune deficiencies, including positive HIV antibody tests.
•9. Patient is in the active stage of HBV or HCV.
•10. History of solid organ transplant or bone marrow transplant.
+7 more criteria

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 24, 2023

Primary Completion Date

June 1, 2025

Completion Date

February 1, 2027

Last Updated

October 28, 2024

Enrollment

128

ESTIMATED participants

Conditions

Advanced Solid TumorNSCLC

Interventions

XZB-0004

DRUG

Contacts

Xiujie Zhang

CONTACT

+86-13671737230 zhangxiujie@xuanzhubio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of XZB-0004 in Patients With Solid Tumors

Inclusion Criteria

Exclusion Criteria

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