2022-501507-27-00招募中2 期
"TOPOLOGY" : A phase II study to evaluate the efficacy and toxicities of PLX038, in patients with locally advanced or metastatic triple-negative breast cancer
Institut Curie, Institut Curie1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年10月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Best tumor response (defined as PR or CR in the first 6 months of treatment, assessed by investigators per RECIST v1.1 criteria)
研究概览
简要总结
Efficacy of PLX038 on response rate
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Treatment and follow-up period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Willing and able to comply with the protocol and provide written informed consent prior to study-specific screening procedures
- •Patients whose cancer has a CPS score ≥10 must have received prior pembrolizumab unless (i) contra-indicated (ii) CPS score or pembrolizumab not available at time of first line treatment start
- •Resolution of chemotherapy and radiation therapy related toxicities to NCI-CTCAE version 5.0 Grade 1 or lower severity, except for stable sensory neuropathy (≤ Grade 2), alopecia (any grade), presence of clinically managed chronic autoimmune AEs from prior immune therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ function (obtained within 14 days prior to treatment start) as evidenced by: i. Absolute neutrophil count (ANC) ≥ 1.5 X 109/L; ii. Hemoglobin (Hgb) ≥ 9 g/dL; iii. Platelet count ≥ 100 X 109/L; iv. Bilirubin ≤ 1.5 X upper limit of normal (ULN), except for patients with a documented history of Gilbert’s disease (≤ 2 X ULN); v. Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5 X ULN (for patients with liver metastases ≤ 5 X ULN); vi. Alkaline phosphatase (AP) ≤ 3 X ULN (for patients with liver metastases, ≤ 5 X ULN); vii. Serum creatinine ≤ 1.5 mg/dL (133 μmol/L) or calculated creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula); viii. Women of childbearing potential (WCBP): negative serum pregnancy test
- •Patients covered by social security or health insurance in compliance with the national legislation relating to biomedical research
- •Age ≥ 18 years
- •Females and males with cytologically or histologically confirmed breast carcinoma (either the primary or metastatic lesions)
- •Locally advanced or metastatic disease that is not amenable to curative treatment
- •Triple negative breast cancer (both ER and PR <10%, HER2-negative or HER2-low)
- •Measurable disease (per RECIST version 1.1)
- •Prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, taxane and sacituzumab-govitecan (unless not medically appropriate or contraindicated for the patient)
- •Received a minimum of two prior cytotoxic chemotherapy regimens for locally advanced or metastatic breast cancer
- •Patients with known gBRCA mutations must have received a PARP inhibitor in the metastatic setting.
排除标准
- •Patients who had a last dose of IV chemotherapy within 21 days, last dose of oral cytotoxic chemotherapy, radiotherapy, biological therapy, or investigational therapy within 14 days prior to treatment start
- •Severe/uncontrolled intercurrent illness within the previous 28 days prior to inclusion
- •Significant known cardiovascular impairment (NYHA CHF > grade 2, unstable angina, myocardial infarction within the previous 6 months prior to inclusion, or existing unstable cardiac arrhythmia)
- •Any other significant medical, psychological, social or geographic conditions that in the opinion of the Investigator would impair study participation or cooperation
- •Patients deprived of their liberty or under guardianship
- •Patients who had any major surgery within 28 days prior to inclusion
- •Patients with chronic inflammatory bowel disease and/or bowel obstruction
- •Concomitant use of other agents for the treatment of cancer or any investigational agent(s)
- •Brain metastases, unless local therapy was completed and use of corticosteroids for this indication discontinued for at least 3 weeks prior to inclusion. Signs or symptoms of brain metastases must be stable for at least 28 days prior to inclusion. No known progression of brain metastases (by imaging as assessed by RECIST) can have occurred. Patients with leptomeningeal disease or meningeal carcinomatosis are excluded
- •Women who are either pregnant, lactating, planning to get pregnant
- •Patients receiving pharmacotherapy for hepatitis B or C, tuberculosis, or HIV
- •Patients with known liver disease diagnosed with Child-Pugh A or higher cirrhosis
- •Prior stage III or IV malignancy (other than breast cancer)
结局指标
主要结局
Best tumor response (defined as PR or CR in the first 6 months of treatment, assessed by investigators per RECIST v1.1 criteria)
Best tumor response (defined as PR or CR in the first 6 months of treatment, assessed by investigators per RECIST v1.1 criteria)
次要结局
- Time to response (TTR), Duration of Response (DoR), Progression free survival (PFS) and Overall Survival (OS)
- AEs and SAEs (all grade, per NCI-CTCAE v5.0)
- Association between PLX038 efficacy and homologous recombination (HR) defect (assessed by HR genes mutational status and BCRAness phenotype), replication stress-related biomarkers such as SFLN11 expression, RB1 loss
- PK/PD analysis
- Exploratory: Association between PLX038 efficacy and tumor or blood biomarkers.
- Exploratory: Centrally determined ORR and PFS.
研究者
François-Clément BIDARD
Scientific
Institut Curie
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Iparomlimab and Tuvonralimab Injection in Combination With Lenvatinib or Axitinib for the Treatment of Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma That Has Failed First-Line Systemic TherapyNCT07277972Tianjin Medical University Cancer Institute and Hospital36
已完成
4 期
PURE2024-515542-16-03Stichting Amsterdam UMC25
已完成
4 期
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272
尚未招募
2 期
Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)NCT07266155Longbio Pharma30
招募中
2 期
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLCNCT07269782Shanghai Henlius Biotech60