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Advanced MalignanciesPhase 1NCT06206915

Phase I Study of XZ120 in Malignant Tumors

A Phase 1 study testing XZ120 injection in people with Advanced Malignancies, run by Shandong New Time Pharmaceutical Co., LTD.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This research includes two parts: the first part of the patients with late malignant tumor monotherapy study, at the beginning of the second part in treat DLBCL and research on combination therapy in patients with advanced breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignancies
What is being tested?
XZ120 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
No sites listed yet
Study dates
1 Feb 2024to 1 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • male or female aged ≥18 years old;
  • The enrolled population was divided into the first part of monotherapy and the second part of combination therapy:
  • The first part of the monotherapy study was as follows:
  • A: single drug dose escalation is confirmed by histology and cytology and received a standard after treatment failure or intolerance to standard treatment or for other reasons can not accept standard or the lack of effective treatment of patients with late malignant tumor; B:Single-agent dose expansion: patients with histologically or cytologically confirmed advanced breast cancer who are eligible for standard anthracycline monotherapy;
  • The second part of the combination therapy dose expansion phase consists of the following cohorts:
  • Cohort 1: the pathology diagnosed patients with DLBCL treated first; Cohort 2: Histologically or cytologically confirmed advanced breast cancer patients eligible for anthracycline-based standard therapy;
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  • Note: The patients with advanced breast cancer met any of the following criteria: ① Initially diagnosed as inoperable locally advanced or metastatic breast cancer; (2) did not receive chemotherapy after the eradicative resection of recurrent or metastatic breast cancer; ③ Recurrent or metastatic breast cancer after receiving anthracyclines for more than 12 months;
  • subjects with at least one measurable and evaluable target lesion were enrolled in the dose-expansion phase;
  • patients with ECOG performance status score of 0-1;
  • dose extension stage lymphoma patients international prognostic index (IPI) score of 0 ~ 2 points;
  • the researchers determine subjects were expected to survive a period of 3 months or more;
  • heart echocardiography measured LVEF 50% or higher;
  • important organ function meet the following requirement (first dose not allowed within 2 weeks before blood transfusion treatment, and use the growth factors of drug) : Blood routine: absolute neutrophil count (ANC) ≥1.5×109/L; The platelet count 75 x 109 / L or higher; Hemoglobin (Hb) ≥90g/L; Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN, total bilirubin (TBIL) ≤1.5×ULN; If there is liver metastasis, AST and ALT≤5×ULN, TBIL≤3×ULN; Renal function: serum creatinine (Cr) <1.5×ULN or creatinine clearance ≥50mL/min (Cr≥1.5×ULN); coagulation function: international standardization ratio (INR) 1.5 x ULN or less and part activated clotting time (APTT) live enzymes acuities were 1.5 x ULN;
  • understand the procedure and content of the trial and sign the informed consent form voluntarily.

Who cannot join

  • always use too much Doxorubicin (or pirarubicin) > total cumulative dose of 360 mg/m2, or epirubicin total cumulative quantity > 600 mg/m2;
  • patients received antineoplastic therapy 4 weeks before the first dose or within 5 half-lives of the drug, whichever was less; Patients who received a modern traditional Chinese medicine preparation with anti-tumor effect approved by NMPA within 2 weeks before the first medication;
  • Prednisone acetate tablets at a maximum dose of >100mg or equivalent cortisol for more than 5 days for the purpose of controlling lymphoma symptoms in patients with lymphoma; For other purposes, use of prednisone acetate tablets at a dose of >30mg per day or a cortisol equivalent for more than 10 days (for patients receiving ≤30mg per day of prednisone acetate tablets or a cortisol equivalent, there was a written record of stable use of the dose for at least 4 weeks before randomization);
  • patients with high-grade B-cell lymphoma;
  • the toxicity of previous antineoplastic therapy has not recovered to ≤ grade 1 according to CTCAE version 5.0 definition (except alopecia);
  • patients with other malignant tumors within 5 years before enrollment, except for the following: (1) radical cervical carcinoma in situ or non-melanoma skin cancer; (2) second primary cancer after radical resection without recurrence within 5 years; (3) The investigators thought that both patients with double primary cancers might benefit from this study; (4) if the metastatic lesion was clearly excluded from the primary tumor;
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  • primary central nervous system (CNS) malignant tumor, CNS metastasis failed by local treatment, and carcinomatous meningitis; Patients with asymptomatic brain metastases or clinically stable neurological symptoms and no need for steroids and other treatments for brain metastases for more than 4 weeks were eligible for enrollment.
  • patients with a history of organ or allogeneic bone marrow transplantation or autologous stem cell transplantation within 3 months before the first dose;
  • patients who underwent major surgery within 4 weeks before the first dose or minor surgery within 2 weeks before the first dose or who have not recovered from surgery (excluding diagnostic surgery);
  • hepatitis b: HBsAg positive and/or HBcAb positive, and HBV DNA drop degree is higher than 2000 iu/mL or 104 copies/mL (hepatitis b virus infection should receive antiviral treatment according to local standard treatment guidelines and willing to accept the antiviral treatment) during the whole research; C: HCV antibody positive, and HCV RNA upper limit of normal value is higher than research center;
  • human immunodeficiency virus antibody (Anti-HIV) positive and active syphilis infection;
  • patients with uncontrolled or severe cardiovascular disease, congestive heart failure (NYHA class Ⅱ or above), unstable angina pectoris, myocardial infarction and other cardiovascular diseases within 6 months before the first drug administration; Patients with uncontrolled hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥100mmHg);
  • has the following patients medical history, including but not limited to active autoimmune diseases, active infection (such as active tuberculosis), severe mental illness, serious endocrine diseases such as serious abnormal thyroid function;
  • for the first time to give medicine have received within 4 weeks before any other clinical trial drug/instruments treatment;
  • with a history of drug abuse or alcohol abuse within 6 months before the first drug administration;
  • patients with a history of severe allergy or known previous allergy to anthracyclines or anthradiones, or to any component of the investigational drug;
  • planning to receive live or live attenuated vaccine within 4 weeks before the first dose or during the study;
  • pregnancy or lactation women, women of childbearing age subjects or partner for women of child-bearing age male subjects to study period, and at the end of the study medication use medical certification within six months after effective contraceptive measures (such as intrauterine device or a condom);
  • the researchers determine doesn't fit into the group.

About this study

Official title: To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of XZ120 in Patients With Malignant Tumors in a Phase Ⅰ Clinical Trial

This research includes two parts: the first part of the patients with late malignant tumor monotherapy study, at the beginning of the second part in treat DLBCL and research on combination therapy in patients with advanced breast cancer.

Research purpose: to evaluate XZ120 safety, tolerability, for the treatment of malignant tumor patients pharmacokinetic characteristics and preliminary effectiveness.

Being tested
XZ120 injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XZ120 injectionDrug

    in Part One：XZ120 monotherapy, IV, no less than 60min, Q3W dose escalation study: 4 dose group (0.75 mg/m2, 1.5 mg/m2, 2.25 mg/m2, 3.0 mg/m2) Dose expansion study: MTD dose

Study groups in NCT06206915
Study groupRoleWhat they receive
XZ120 monotherapyExperimentalNot described
Receives: Drug: XZ120 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of XZ120 treatment-emergent adverse events

    Adverse Events

    Measured: 36 courses（approximately 2 years）

  2. The maximum tolerated dose and/or the recommended phase II dose of XZ120

    Dose Finding

    Measured: Course 1 （the first 3 weeks of treatment）

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2024
  2. Study start1 Feb 2024 (estimated)
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

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
123 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06206915
Sponsor's protocol ID
NTP-XZ120-001
Status last verified
Dec 2023
First submitted
20 Dec 2023
Last updated
16 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XZ120 injection in people with Advanced Malignancies, run by Shandong New Time Pharmaceutical Co., LTD.

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 14 inclusion and 19 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: opening soon, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of XZ120 treatment-emergent adverse events (time frame: 36 courses（approximately 2 years）). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06206915.

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 16 Jan 2024.

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