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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
XZB-0004
DrugPart 1a: 100mg BID, 150mg BID, and 200mg BID of XZB-0004 are planned to be evaluated, and the possibility of exploring higher or lower doses is not ruled out. Continuous administration of XZB-0004 for 21 days is a treatment cycle. Part 1b: XZB-0004 in combination with Penpulimab in subjects with advanced NSCLC or solid tumors, starting at a dose level down from the RP2D of XZB-0004 monotherapy- cohort 1: Advanced or metastatic NSCLC with advanced disease progression after treatment with PD-1 or PD-L1 inhibitors; cohort 2: Advanced or metastatic NSCLC with advanced disease progression after platinum-containing chemotherapy without prior use of any immunocheckpoint inhibitors; cohort3: Advanced or metastatic solid tumors that cannot be radically cured by surgery or local therapy, including but not limited to urothelial carcinoma, melanoma, etc. Subjects had disease progression since last antitumor therapy, no availability or intolerance or refusal of standard therapy.
Treatment groups
128 Participants
are divided into 1 treatment groupGroup A: XZB-0004Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum tolerated dose (MTD) (for Part 1a)
Determine MTD of XZB-0004
Time frame
Up to 3 weeks2
Recommended phase 2 dose (RP2D）(for Part 1a)
Determine RP2D of XZB-0004
Time frame
Up to 3 weeks3
Overall Response Rate (ORR) (for Part 1b)
Number of participants who achieved a best response of either complete response (CR) or partial response (PR) during treatment evaluated by investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame
Up to 2-3 yearsSecondary outcomes
1
Pharmakinetic parameter - AUC0-t (for Part 1a and Part 1b)
To determine AUC0-t of XZB-0004
Time frame
Up to 63 days2
Pharmakinetic parameter - AUC0-∞ (for Part 1a and Part 1b)
To determine AUC0-∞ of XZB-0004
Time frame
Up to 63 days3
Pharmakinetic parameter - Cmax (for Part 1a and Part 1b)
To determine Cmax of XZB-0004
Time frame
Up to 63 days4
Pharmakinetic parameter - Tmax (for Part 1a and Part 1b)
To determine Tmax of XZB-0004
Time frame
Up to 63 daysSponsors and contacts
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Source ClinicalTrials.gov