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

Exclusion Criteria

• •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;
• •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.
• •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.
• •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.