Advanced Solid TumorPhase 1NCT05772455
A Study of XZB-0004 in Patients With Solid Tumors
A Phase 1 study testing XZB-0004 in people with Advanced Solid Tumor and NSCLC, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor, NSCLC
- What is being tested?
- XZB-0004
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 24 Mar 2023to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Have a performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- Have adequate organ function.
Show all 10Show fewer
- 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.
- Have a life expectancy greater than 3 months.
- Eligible patients (male and female) who are fertile must agree to at least use a reliable contraceptive method with partner.
- Willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- 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.
- Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug.
- Patient with heart function impaired or clinically significant heart disease.
Show all 17Show fewer
- Any condition or illness that, in the opinion of the Investigator, would interfere with the evaluation of the safety of the study drug.
- History of immune deficiencies, including positive HIV antibody tests.
- Patient is in the active stage of HBV or HCV.
- History of solid organ transplant or bone marrow transplant.
- Any other malignant tumor has been diagnosed within 5 years.
- Has known Primary tumor of the central nervous system or central nervous system metastase.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage were present within 4 weeks before the first dose of the trial drug.
- Subjects with psychiatric disorders that may affect trial compliance.
- history of Alcoholism or drug abuse.
- Pregnant or breastfeeding.
- The researchers considered that there were some cases that were not suitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Caicun Zhou, +86-13301825532, caicunzhoudr@163.com
About this study
Official title: A Phase I, Open-label, Dose-escalation Study of the Safety, Pharmacokinetics and Efficacy of the XZB-0004 in Patients With Solid Tumours
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.
- Conditions
- Advanced Solid Tumor, NSCLC
- Being tested
- XZB-0004
- Keywords
- XZB-0004, AXL inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XZB-0004Drug
Part 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.
| Study group | Role | What they receive |
|---|---|---|
| XZB-0004 | Experimental | Not described Receives: Drug: XZB-0004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) (for Part 1a)
Determine MTD of XZB-0004
Measured: Up to 3 weeks
Recommended phase 2 dose (RP2D）(for Part 1a)
Determine RP2D of XZB-0004
Measured: Up to 3 weeks
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
Measured: Up to 2-3 years
Secondary outcomes (13)
Pharmakinetic parameter - AUC0-t (for Part 1a and Part 1b)
To determine AUC0-t of XZB-0004
Measured: Up to 63 days
Pharmakinetic parameter - AUC0-∞ (for Part 1a and Part 1b)
To determine AUC0-∞ of XZB-0004
Measured: Up to 63 days
Pharmakinetic parameter - Cmax (for Part 1a and Part 1b)
To determine Cmax of XZB-0004
Measured: Up to 63 days
Pharmakinetic parameter - Tmax (for Part 1a and Part 1b)
To determine Tmax of XZB-0004
Measured: Up to 63 days
Pharmakinetic parameter - t½ (for Part 1a and Part 1b)
To determine t½ of XZB-0004
Measured: Up to 63 days
Pharmakinetic parameter - CL/F (for Part 1a and Part 1b)
To determine CL/F of XZB-0004
Measured: Up to 63 days
Pharmakinetic parameter - Vz/F (for Part 1a and Part 1b)
To determine Vz/F of XZB-0004
Measured: Up to 63 days
Overall Response Rate (ORR) (for Part 1a)
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
Measured: Up to 2-3 years
Progression free survival (PFS) (for Part 1a and Part 1b)
PFS is defined as the time from the date of first dose of XZB-0004 till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Measured: Up to 2-3 years
Duration of response (DOR) (for Part 1a and Part 1b)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: Up to 2-3 years
Disease control rate (DCR) (for Part 1a and Part 1b)
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.
Measured: Up to 2-3 years
Overall survival (OS) (for Part 1a and Part 1b)
OS is the time from the date of first dose of XZB-0004 to death due to any cause.
Measured: Up to 2-3 years
Incidence and severity of adverse events (AEs)(for Part 1b)
An adverse event (AE) is any untoward medical occurrence or the deterioration of existing medical event in a clinical study subject administered an investigational drug, which does not necessarily have an unequivocal causal relationship with the investigational product.
Measured: Up to 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start24 Mar 2023
- Primary completionJun 2025 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Xuanzhu Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772455
- Sponsor's protocol ID
- XZB-0004-1001
- Status last verified
- Oct 2024
- First submitted
- 20 Feb 2023
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose-escalation Study of the Safety, Pharmacokinetics and Efficacy of the XZB-0004 in Patients With Solid Tumours
- ClinicalTrials.gov ID
- NCT05772455
- Acronym / sponsor ID
- XZB-0004-1001
- Conditions
- Advanced Solid Tumor, NSCLC
- Keywords
- XZB-0004, AXL inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XZB-0004 | Experimental | Drug: XZB-0004 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Have a performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
Key exclusion criteria (17 listed)
- 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.
- Inability to swallow, intestinal obstruction or other factors that affect the taking and absorption of the drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XZB-0004Part 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. | Drug | XZB-0004 |
Primary outcome
Maximum tolerated dose (MTD) (for Part 1a)
Time frame: Up to 3 weeks
Determine MTD of XZB-0004
Recommended phase 2 dose (RP2D）(for Part 1a)
Time frame: Up to 3 weeks
Determine RP2D of XZB-0004
Overall Response Rate (ORR) (for Part 1b)
Time frame: Up to 2-3 years
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
13 secondary outcomes
Pharmakinetic parameter - AUC0-t (for Part 1a and Part 1b)
Time frame: Up to 63 days
Pharmakinetic parameter - AUC0-∞ (for Part 1a and Part 1b)
Time frame: Up to 63 days
Pharmakinetic parameter - Cmax (for Part 1a and Part 1b)
Time frame: Up to 63 days
Pharmakinetic parameter - Tmax (for Part 1a and Part 1b)
Time frame: Up to 63 days
Pharmakinetic parameter - t½ (for Part 1a and Part 1b)
Time frame: Up to 63 days
Pharmakinetic parameter - CL/F (for Part 1a and Part 1b)
Time frame: Up to 63 days
Pharmakinetic parameter - Vz/F (for Part 1a and Part 1b)
Time frame: Up to 63 days
Overall Response Rate (ORR) (for Part 1a)
Time frame: Up to 2-3 years
Progression free survival (PFS) (for Part 1a and Part 1b)
Time frame: Up to 2-3 years
Duration of response (DOR) (for Part 1a and Part 1b)
Time frame: Up to 2-3 years
Disease control rate (DCR) (for Part 1a and Part 1b)
Time frame: Up to 2-3 years
Overall survival (OS) (for Part 1a and Part 1b)
Time frame: Up to 2-3 years
Incidence and severity of adverse events (AEs)(for Part 1b)
Time frame: Up to 2-3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
Related trials for Advanced Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XZB-0004 in people with Advanced Solid Tumor and NSCLC, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiujie Zhang (+86-13671737230, zhangxiujie@xuanzhubio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (for Part 1a) (time frame: Up to 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.