NCT04539496Unknown1 期
A Multicenter, Open-label Phase I/II Study of XZP-3287 in Metastasis Solid Tumors in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Single agent and combination dose exploration study：AE evaluation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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.
排除标准
- •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.
研究组 & 干预措施
Dose Escalation and Expansion Study
Experimental
To determine the MTD and RP2D of XZP-3287
干预措施: XZP-3287 (Drug)
Combination Therapy Study
Experimental
To determine the RP2D of XZP-3287 combined with endocrine therapy
干预措施: XZP-3287;Letrozole;Anastrozole;Fulvestrant (Drug)
A Phase 2 Study of Single-Agent XZP-3287 in Patients After Failure of Multi-Line Therapy
Experimental
To 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
干预措施: XZP-3287 (Drug)
结局指标
主要结局
Single agent and combination dose exploration study：AE evaluation
时间窗: Up to 30 days after the end of treatment
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)
The phase II study：Objective response rate (ORR) assessed by Independent Review Committee (IRC)
时间窗: 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
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.
次要结局
- Progression free survival (PFS)(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)
- Overall survival (OS)(From baseline to the death from any cause, assessed approximately up to 2 years after the last entered participant)
- Duration of response (DoR)(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)
- Disease control rate (DCR)(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)
- Clinical benefit rate (CBR)(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)
- Pharmacokinetics (PK)(From baseline up to month 3)
- Investigator-assessed ORR(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)
- The phase II study：AE evaluation(Up to 30 days after the end of treatment)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Study of Zimberelimab(GLS-010) Combined With AVD for Newly Diagnosed Early-stage Hodgkin's LymphomaClassical Hodgkin LymphomaNCT05900765Sun Yat-sen University54
终止
1 期
ZN-c3 in Adult Participants With Metastatic Colorectal CancerMetastatic Colorectal CancerNCT05743036K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc44
已完成
3 期
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet SyndromeDravet SyndromeNCT02926898Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.87
已完成
2 期
Dociparstat Sodium (CX-01) Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid LeukemiaAcute Myeloid LeukemiaNCT02873338Chimerix75
已完成
1 期
The Combination of Rad001 and Rituximab In Patients With Non-hodgkin's LymphomasNon-Hodgkin's LymphomasNCT01567475The Lymphoma Academic Research Organisation21