DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer

Официальное название

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)

Обзор

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.

Вмешательства

• Биопрепарат HER2 - primed Dendritic cells
  Dendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs. Participants will be treated at the following dose levels: Dose level 1: HER2 - primed Dendritic cells dose 10-20 million Dose level 2: HER2 - primed Dendritic cells dose 30-50 millio
• Биопрепарат HER3 - primed Dendritic cells
  Dendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs. Participants will be treated at the following dose levels: Dose level 1: HER3 - primed Dendritic cells dose 10-20 million Dose level 2: HER3 - primed Dendritic cells dose 30-50 millio

Первичные конечные точки

• Maximum Tolerated Dose (MTD) [Срок оценки: 4 weeks after start of treatment]

Вторичные конечные точки (7)

• Number of Dose Limiting Toxicities [Срок оценки: 5 weeks after start of treatment]
• Participants with pathological complete response after receiving HER2/HER3 DC1 intratumoral injections [Срок оценки: Up to 24 weeks]
• Participants with clinical and radiological responses after receiving HER2/HER3 DC1 [Срок оценки: Up to 36 Months]
• Participants with clinical and radiological partial responses after receiving HER2/HER3 DC1 [Срок оценки: Up to 36 Months]
• Participants with clinical and radiological progression of disease after receiving HER2/HER3 DC1 [Срок оценки: Up to 36 Months]
• Participants with clinical and radiological stable disease after receiving HER2/HER3 DC1 [Срок оценки: Up to 36 Months]
• Participants with Recurrence Free Survival (RFS) [Срок оценки: Up to 36 Months]

Критерии участия

Критерии включения

• 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 1.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Moffitt Cancer Center — Tampa

Идентификаторы

NCT: NCT05504707 · MCC-20897

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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