A Study of XZB-0004 in Patients With Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXuanzhu Biopharmaceutical Co., Ltd.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- XZB-0004
Treatment groups
128 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov