NCT05504707招募中1 期
Phase 1 Dose-Escalation, Dose-Expansion Trial of Intratumoral HER2- and HER3-Primed Dendritic Cells Injections for the Treatment of Early-Stage TNBC and ER Low Positive Breast Cancer (DecipHER)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
The purpose of the study is to find out if an investigational vaccine called Dendritic Cell (DC) vaccine given together with standard of care chemotherapy drugs can help people with Triple Negative and HR low positive 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
- •A diagnosis of HER2-negative breast cancer.
- •Diagnosis of HR negative or HR low positive tumor.
- •Clinical stage T1c, nodal stage N1-N2 or stage T2-4, nodal stage N0-N2 breast cancer.
- •Participant must be medically and surgically appropriate to undergo neoadjuvant chemotherapy regimen followed by standard of care local therapy as determined by their treating physician.
- •Age ≥18 years.
- •ECOG performance status 0 or
- •Patients must have normal organ and marrow function, as defined below, within 14 days of registration:
- •*Absolute neutrophil count (ANC) ≥ 1500/μL
- •*Platelets ≥ 75 000/μL
- •*Total bilirubin ≤ 1.5 x institutional ULN, except patients with Gilbert's syndrome in whom total bilirubin must be < 3.0 mg/dL
- •*AST/ALT ≤ 3 x institutional ULN
- •*Creatinine ≤ 1.5 x institutional ULN
- •Left ventricular ejection fraction above institutional lower limit of normal (by echocardiogram or MUGA scan).
- •Female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. Effective methods of contraception must be used throughout the study and for 5 months following the last dose. To show that women do not have childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (and not because of/following chemotherapy) or patients must be surgically sterile.
- •Ability to understand and the willingness to sign a written informed consent agreement prior to study registration.
排除标准
- •Patients who received prior anthracycline-based chemotherapy for the treatment of any cancer.
- •Patients with inflammatory breast cancer.
- •Patients must not be receiving any other investigational agents or active antineoplastic therapies.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune-suppressive treatment, including chronic prolonged systemic corticosteroid use (defined as corticosteroid use lasting one month or more).
- •Female patients who are pregnant or nursing.
- •No other prior malignancy is allowed, except for the following: a. adequately treated basal-cell or squamous-cell skin cancer, b. in situ cervical cancer, c. or any other cancer from which the patient has been disease free for at least 3 years.
- •History of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
- •History of positive test for Hepatitis B or Hepatitis C virus indicating acute or chronic infection.
- •Patients who have received a live attenuated vaccine ≤ 30 days prior to registration.
- •Unable to comply with the treatment schedule and study procedures for any reason.
- •Previously treated with breast cancer-directed vaccine therapies in prior 3 months.
- •Previously treated with any form HER2- or HER3-primed DC1 therapy.
研究组 & 干预措施
Dendritic Cell Vaccine dose Escalation
Experimental
Dose escalation to determine the maximum tolerated dose (MTD) of HER2- and HER3- primed DC1 study vaccines. Participants will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 3 dose levels will be used.
干预措施: HER2 - primed Dendritic cells (Biological)
Dendritic Cell Vaccine dose Escalation
Experimental
Dose escalation to determine the maximum tolerated dose (MTD) of HER2- and HER3- primed DC1 study vaccines. Participants will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A total of 3 dose levels will be used.
干预措施: HER3 - primed Dendritic cells (Biological)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 4 weeks after start of treatment
Maximum Tolerated Dose (MTD) of HER2- and HER3- primed DC1 study vaccines. The MTD will be defined as the highest dose level at which \< 2 of 6 patients experience dose-limiting toxicities (DLTs).
次要结局
- Participants with clinical and radiological responses after receiving HER2/HER3 DC1(Up to 36 Months)
- Participants with clinical and radiological progression of disease after receiving HER2/HER3 DC1(Up to 36 Months)
- Participants with pathological complete response after receiving HER2/HER3 DC1 intratumoral injections(Up to 24 weeks)
- Participants with clinical and radiological partial responses after receiving HER2/HER3 DC1(Up to 36 Months)
- Number of Dose Limiting Toxicities(5 weeks after start of treatment)
- Participants with Recurrence Free Survival (RFS)(Up to 36 Months)
- Participants with clinical and radiological stable disease after receiving HER2/HER3 DC1(Up to 36 Months)
研究者
研究点 (2)
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