NCT03720431Unknown1 期
A Phase 1b, Open-Label, Safety and Tolerability Study of TTAC-0001 in Combination With Pembrolizumab in Patients With Metastatic Triple-Negative Breast Cancer
PharmAbcine2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2019年1月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Dose limiting toxicities
研究概览
简要总结
This is a phase 1b, open-Label clinical trial to determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) of TTAC-0001 administered in combination with pembrolizumab in patients with metastatic triple-negative breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients ≥18 years old
- •Histologically proven metastatic breast carcinoma with triple negative receptor status (Estrogen receptor, Progesterone receptor and human epidermal growth factor receptor 2 [HER2] negative) by IHC and Fluorescence in situ hybridization (FISH) according to ASCO-CAP guideline
- •At least one confirmed measurable lesion by RECIST 1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •A person who satisfies the following criteria in hematologic, renal, and hepatic function tests performed within 7 days prior to screening:
- •(1) Hematologic tests
- •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- •Platelets ≥ 100 x 109/L
- •Haemoglobin ≥ 9.0 g/dL (2) Blood coagulation tests
- •Prothrombin time (PT) ≤ 1.5 x Upper limit of normal (UNL)
- •Activated partial thromboplastin Time (aPTT) ≤ 1.5 x UNL (3) Hepatic function tests
- •Total bilirubin ≤ 1.5 x UNL
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastasis) (4) Renal function test
- •≤1.5 × ULN or creatinine clearance (CrCl) ≥30 mL/min for patient with creatinine levels >1.5 × institutional ULN 6) At least 12 weeks of expected life expectancy 7) The patient (or legally acceptable representative if applicable) is able and willing to provide written informed consent for the trial.
排除标准
- •Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. (Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) controlled by curative therapy are not excluded)
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment
- •Has a history of (non-infectious) pneumonitis/interstitial lung diseases that required steroids or current pneumonitis/interstitial lung disease.
- •Has an active infection requiring systemic therapy
- •Uncontrolled hypertension (systolic blood pressure [SBP]> 150 or diastolic blood pressure [DBP]> 90 mmHg)
- •Uncontrolled seizures
- •Class III or IV heart failure by New York Heart Association (NYHA) classification
- •Has oxygen-dependent chronic disease
- •Active psychiatric disorder (schizophrenia, major depressive disorder, bipolar disorder etc.). Treated depression with ongoing antidepressant medication is not an exclusion
- •History of abdominal fistula or gastrointestinal perforation within 6 months prior to start of study drug
- •History of serious gastrointestinal haemorrhage within 6 months prior to start of study drug
- •History of severe arterial thromboembolic event within 12 months of start of study drug
- •Serious grade 4 venous thromboembolic event including pulmonary embolism
- •History of hypertensive crisis or hypertensive encephalopathy
- •History of posterior reversible encephalopathy syndrome
- •Planned surgery within 4 weeks post last dose
- •Moderate to severe proteinuria
- •Requiring therapeutic anticoagulation with warfarin at baseline
- •Not recovered below National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 1 or baseline from AEs due to previous therapy
- •Treatment with systemic chemotherapy, hormonal therapy, immunotherapy or biologic therapy within 2 weeks prior to the baseline visit
- •Has received prior radiotherapy within 2 weeks of start of study treatment.
- •Undergone major surgery requiring general anaesthesia or a respiratory assistance device within 4 weeks prior to the baseline visit
- •Treated with other investigational drugs within 4 weeks prior to the baseline visit for this study
- •Female who is pregnant* or lactating and of childbearing potential who does not agree to a reliable and adequate method of contraception
- •A known history of severe drug hypersensitivity or hypersensitivity to a therapy similar to the study drugs
- •Unable to participate in the trial according to the investigator's decision.
- •Previous therapy with vascular endothelial growth factor (VEGF)-targeted agents including (but not limited to) bevacizumab
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher irAE
研究组 & 干预措施
TTAC-0001 and pembrolizumab
Experimental
TTAC-0001 and pembrolizumab combination therapy will be administered.
干预措施: TTAC-0001 and pembrolizumab combination (Drug)
结局指标
主要结局
Dose limiting toxicities
时间窗: During the first cycle (every cycle is 21 days) of treatment
The frequency and percentage of DLT will be presented by dose level
Adverse events
时间窗: From date of screening visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
The frequency and percentage of AEs will be presented by dose level
Immunogenicity
时间窗: From date of screening visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Presence anti-drug antibody (ADA) will be listed
次要结局
- Overall response rate(At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years (every cycle is 21 days)])
- Disease control rate(At every 2nd cycles until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years (every cycle is 21 days))
- Progression free survival(From date of screening visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
- Overall survival(From date of screening visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
研究者
研究点 (2)
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