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Metastasis Solid TumorsPhase 1/2NCT04539496

A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors

A Phase 1/2 study testing XZP-3287 and XZP-3287;Letrozole;Anastrozole;Fulvestrant in people with Metastasis Solid Tumors and Advanced Breast Cancer, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study includes single agent/combination dose exploration study and the phase II study. The primary purpose of the dose exploration study is to determine the maximum tolerated dose(MTD)/recommended phase II dose(RP2D) of XZP-3287 and assess its safety and preliminary efficacy in solid tumor patients. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
XZP-3287 and XZP-3287;Letrozole;Anastrozole;Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
1 siteChina
Study dates
22 May 2018to 31 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Single agent and combination dose exploration study：Patient is an adult male/female 18~70 years old; the phase II study：Patient is an adult male/female ≥ 18 years old;
  • Single agent dose escalation study ：Patients with a histologically or cytologically confirmed diagnosis of a solid tumor for which Standard treatment failure or no further effective standard treatment is available.
  • Combination dose exploration study：Patients with locally advanced or metastatic breast cancer with hormone receptor positive (HR+) and her2-negative (HER2-) were not eligible for surgical resection or radiotherapy for the purpose of cure, and had no clinical indications for chemotherapy, and received endocrine therapy ≤1 line.
  • The phase II study: Locally advanced or metastatic breast cancer diagnosed histologically or cytologically not suitable for surgery or radical radiotherapy; HR+ and HER2- ; have locally advanced disease not amenable to curative treatment by surgery or metastatic disease; progress after previous endocrine therapy; at least 1 chemotherapy regimen in the previous adjuvant or metastasis contains paclitaxel; there should be at least 2 prior chemotherapy regimens;
  • At least one measurable lesion (based on RECIST v1.1);
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
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  • Have recovered from the acute effects of therapy (until the toxicity resolves to either baseline or Grade 1) except for residual alopecia;
  • Adequate organ and marrow function;
  • The life expectancy of the patient was determined by the investigator to be ≥12 weeks;
  • Fertile male or female patients must agree to use an effective contraceptive method during the study period and for three months after the last study medication;
  • Patient has signed informed consent before any trial related activities.

Who cannot join

  • Single agent and combination dose exploration study：Patients with known uncontrolled or symptomatic CNS metastases; The phase II study：Have central nervous system (CNS) metastasis, or Have visceral crisis, or Inflammatory breast cancer.
  • Have received an autologous or allogeneic stem-cell transplant.
  • Patient has impairment of gastrointestinal (GI) function or GI disease.
  • Single agent and combination dose exploration study：Any other malignancy was diagnosed within 3 years prior to enrollment, except for basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix, which is adequately treated and the disease is stable.
  • The phase II study：Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
  • Subject has impaired cardiac function or heart disease of clinical significance.
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  • Cerebrovascular accidents within 6 months before enrollment, including a history of transient ischemic attack or stroke.
  • Major surgery or surgical treatment due to any cause occurred within 4 weeks prior to enrollment.
  • Presence of any serious and/or uncontrolled disease in the opinion of the investigator that may interfere with the study assessment.
  • Uncontrollable pleural effusion, peritoneal effusion, pericardial effusion in the 4 weeks before the first administration (except for a small amount of effusion detected by imaging examination).
  • A prior history of definite neurological or psychiatric disorders, including epilepsy or dementia.
  • Chronic active HBV, HCV or HIV diseases.
  • Patient who received any CDK4/6 inhibitor or patients who plan surgery, or the investigator determines that surgery or radical radiation therapy is required.
  • Participation in a prior treatment of chemotherapy, radiotherapy, endocrinotherapy, targeted therapy, immunotherapy and any investigational study within 14 days prior to enrollment.
  • Bone marrow suppression therapy, such as GCS-F, EPO, or blood transfusion, was administered within 14 days prior to enrollment.
  • Patient with a known hypersensitivity to any of the excipients in this study.
  • 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.

China1 site

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: A Multicenter, Open-label Phase I/II Study of XZP-3287 in Metastasis Solid Tumors in China

This study includes single agent/combination dose exploration study and the phase II study. The primary purpose of the dose exploration study is to determine the maximum tolerated dose(MTD)/recommended phase II dose(RP2D) of XZP-3287 and assess its safety and preliminary efficacy in solid tumor patients. The phase II study aims to explore the efficacy and safety profiles of XZP-3287 as a single- agent in hormone receptor(HR) positive, human epidermal growth factor receptor 2(HER2) negative advanced breast cancer.

Being tested
XZP-3287, XZP-3287;Letrozole;Anastrozole;Fulvestrant

What participants receive

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

  • XZP-3287Drug

    • 20-560 mg QD, oral
    • 240-480 mg BID, oral

  • XZP-3287;Letrozole;Anastrozole;FulvestrantDrug

    XZP-3287: 360 mg BID, oral; Letrozole: 2.5 mg QD, oral; Anastrozole: 1 mg QD, oral; Fulvestrant: 500 mg intramuscular injection on C1D1, C1D15, the first day of each subsequent cycle (28 days a cycle)

  • XZP-3287Drug

    480 mg BID, oral

Study groups in NCT04539496
Study groupRoleWhat they receive
Dose Escalation and Expansion StudyExperimentalTo determine the MTD and RP2D of XZP-3287
Receives: Drug: XZP-3287
Combination Therapy StudyExperimentalTo determine the RP2D of XZP-3287 combined with endocrine therapy
Receives: Drug: XZP-3287;Letrozole;Anastrozole;Fulvestrant
A Phase 2 Study of Single-Agent XZP-3287 in Patients After Failure of Multi-Line TherapyExperimentalTo determine the efficacy and safety profiles of XZP-3287 as a single- agent in hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer
Receives: Drug: XZP-3287

What is being measured

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

  1. Single agent and combination dose exploration study：AE evaluation

    AEs as characterized by frequency and severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03 for single agent dose exploration study and CTCAE 5.0 for combination exploration study)

    Measured: Up to 30 days after the end of treatment

  2. The phase II study：Objective response rate (ORR) assessed by Independent Review Committee (IRC)

    ORR is the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) as defined by RECIST v1.1.

    Measured: From baseline to the date of first documentation of progression or death , whichever came first, assessed approximately up to 2 years after the last entered participant

Secondary outcomes (8)

  1. Progression free survival (PFS)

    PFS is defined as the time from the date of the first treatment until first observation of objective progressive disease or death, whichever comes first.

    Measured: From baseline to the date of first documentation of progression or death, whichever came first, assessed approximately up to 2 years after the last entered participant

  2. Overall survival (OS)

    OS is defined from the date of the first treatment to the date of death from any cause.

    Measured: From baseline to the death from any cause, assessed approximately up to 2 years after the last entered participant

  3. Duration of response (DoR)

    DoR is defined from the date of CR or PR to date of disease progression or death due to any cause.

    Measured: From baseline to the date of first documentation of progression or death, whichever came first, assessed approximately up to 2 years after the last entered participant

  4. Disease control rate (DCR)

    DCR is the percentage of participants with a best overall response of CR, PR or stable disease (SD) as defined by RECIST v1.1.

    Measured: From baseline to the date of first documentation of progression or death, whichever came first, assessed approximately up to 2 years after the last entered participant

  5. Clinical benefit rate (CBR)

    Percentage of participants with best overall response of CR, PR, or SD with duration of SD for at least 6 Months.

    Measured: From baseline to the date of first documentation of progression or death, whichever came first, assessed approximately up to 2 years after the last entered participant

  6. Pharmacokinetics (PK)

    Mean steady state exposure of XZP-3287 and its metabolites.

    Measured: From baseline up to month 3

  7. Investigator-assessed ORR

    ORR is the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) as defined by RECIST v1.1.

    Measured: From baseline to the date of first documentation of progression or death, whichever came first, assessed approximately up to 2 years after the last entered participant

  8. The phase II study：AE evaluation

    AEs as characterized by frequency and severity (as graded by CTCAE 5.0 )

    Measured: Up to 30 days after the end 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 posted7 Sep 2020
  2. Study start22 May 2018
  3. Primary completion31 Jul 2023
  4. Study completion31 Dec 2025 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04539496
Sponsor's protocol ID
XZP-3287-1001
Status last verified
Sep 2024
First submitted
26 Aug 2020
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang J, Sun T, Tong Z, Hu X, Li W, Yan M, Liu Y, Ouyang Q, Liu X, Fang J, Li H, Li H, Chen W, Gong C, Teng Y, Xu L, Duan X, Liu M, Meng Y, Liu F, Wang L, Xu B. Safety and tolerability of bireociclib for the treatment of advanced solid tumors as monotherapy and in combination with endocrine therapy: a multicenter, open-label, phase 1 clinical trial. BMC Med. 2025 Oct 8;23(1):546. doi: 10.1186/s12916-025-04364-9.

    PubMed 41063198

  • Wang J, Zhang Q, Sun T, Li H, Cheng Y, Tong Z, Li H, Li W, Wang J, Teng Y, Wu X, Cheng J, Chen Z, Zhu Z, Wang L, Liu M, Duan X, Xu L, Xu B. An open-label, single-arm, multicenter, phase II trial of bireociclib as monotherapy for heavily pretreated HR-positive, HER2-negative advanced breast cancer patients: BRIGHT-1 trial. Cancer Commun (Lond). 2025 Jun;45(6):640-653. doi: 10.1002/cac2.70009. Epub 2025 Feb 27.

    PubMed 40013319

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing XZP-3287 and XZP-3287;Letrozole;Anastrozole;Fulvestrant in people with Metastasis Solid Tumors and Advanced Breast Cancer, run by Sihuan Pharmaceutical Holdings Group 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 11 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 19 Sep 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Single agent and combination dose exploration study：AE evaluation (time frame: Up to 30 days after the end of treatment). 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 NCT04539496, which also lists 2 linked publications.

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 19 Sep 2024.

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