Testing a new drug XZB-0004 for patients with solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Pulmonary Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xiujie Zhang
• Email: zhangxiujie@xuanzhubio.com
• Phone: +86-13671737230

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• YSCH-01 Nebulized Therapy for Lung Metastases in NSCLC and Advanced Solid Tumors

  A first-in-human, early-phase study tests a nebulized therapy called YSCH-01 to see if it is safe and shows any signs of benefit for adults with NSCLC or other cancers that have spread to the lungs.

  Recruiting Early Phase 1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing · NCT07793500

• Oral Alintegimod with Ipilimumab followed by Nivolumab for advanced cancer

  This study is testing if a new oral medication called Alintegimod, combined with two other cancer treatments, can help people with advanced solid tumors feel better and live longer.

  Recruiting at 4 sites Phase 1/2 7 Hills Pharma, LLC · Aurora, Colorado and 4 other locations · NCT06362369

• Evaluating CJRB-101 with Pembrolizumab for Advanced Cancer

  This study is testing a new treatment combining CJRB-101 with pembrolizumab to see if it helps people with advanced cancers like lung cancer and melanoma feel better and respond better to their treatment.

  Recruiting at 4 sites Phase 1/2 CJ Bioscience, Inc. · Irvine, California and 3 other locations · NCT05877430

• Evaluating HB0036 for advanced solid tumors

  This study is testing a new treatment called HB0036 to see if it is safe and effective for people with advanced solid tumors, including non-small cell lung cancer.

  Recruiting at 4 sites Phase 1/2 Shanghai Huaota Biopharmaceutical Co., Ltd. · Lafayette, Indiana and 3 other locations · NCT05417321

• Testing a new drug for advanced solid tumors and lymphoma

  This study is testing a new drug called BPI-371153 to see if it is safe and effective for people with advanced solid tumors or lymphoma that hasn’t responded to other treatments.

  Recruiting at 3 sites Phase 1 Betta Pharmaceuticals Co., Ltd. · Chaoyang, Beijing Municipality and 3 other locations · NCT05341557

• Testing TORL-1-23 in patients with advanced cancer

  This study is testing a new treatment called TORL-1-23 to see if it can help people with advanced cancers like ovarian, endometrial, and lung cancer feel better and fight their disease.

  Recruiting at 14 sites Phase 1 TORL Biotherapeutics, LLC · Fullerton, California and 13 other locations · NCT05103683

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.