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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    300
  • sponsor
    Sihuan Pharmaceutical Holdings Group Ltd.
Updated on 25 January 2021

Summary

This study includes Single agent/combination dose exploration study and the phase II study. The primary purpose of this study is to determine the maximum tolerated dose(MTD)/recommended phase II dose(RP2D) of XZP-3287 and its efficacy and safety in hormone receptor(HR) positive, human epidermal growth factor receptor 2(HER2) negative advanced breast cancer.

Details
Condition Advanced Breast Cancer, Metastasis Solid Tumors
Treatment XZP-3287
Clinical Study IdentifierNCT04539496
SponsorSihuan Pharmaceutical Holdings Group Ltd.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Single agent and combination dose exploration studyPatient is an adult male/female 18~70 years old; the phase II studyPatient 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 studyPatients 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 or capecitabine; there should be no more than 2
chemotherapy regimens in the recurrent or metastatic stage
At least one measurable lesion (based on RECIST v1.1)
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
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

Exclusion Criteria

Single agent and combination dose exploration studyPatients with known uncontrolled or symptomatic CNS metastases; The phase II studyHave 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 studyAny 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 studyHave 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
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
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