Testing a new drug XZB-0004 for 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

This study is testing a new drug called XZB-0004 to see if it can safely help people with advanced solid tumors, like lung cancer, especially when used with another treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone, Penpulimab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05772455 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter phase I study evaluating the safety and effectiveness of XZB-0004, a novel AXL inhibitor, in patients with advanced solid tumors, including non-small cell lung cancer (NSCLC). The study consists of two parts: the first part focuses on dose escalation to determine a safe and effective dose, while the second part assesses the efficacy and safety of XZB-0004 in combination with Penpulimab. Participants will be monitored for pharmacokinetics and pharmacodynamics to understand how the drug works in the body.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed diagnoses of solid tumors or NSCLC and measurable disease.

Not a fit: Patients with a life expectancy of less than three months or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors, potentially improving their outcomes.

How similar studies have performed: Other studies involving AXL inhibitors have shown promise, suggesting that this approach may be effective.

Eligibility criteria

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.
11. Any other malignant tumor has been diagnosed within 5 years.
12. Has known Primary tumor of the central nervous system or central nervous system metastase.
13. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage were present within 4 weeks before the first dose of the trial drug.
14. Subjects with psychiatric disorders that may affect trial compliance.
15. history of Alcoholism or drug abuse.
16. Pregnant or breastfeeding.
17. The researchers considered that there were some cases that were not suitable for inclusion.

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Xiujie Zhang

Conditions Advanced Solid Tumor; NSCLC; XZB-0004; AXL inhibitor