Идёт набор NCT06827613

A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors

Фаза I / Фаза II С лечением Triple Negative Locally Advanced Non-resectable Breast Cancer HR+, HER2-, Advanced Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: STAR0602, Sacituzumab Govitecan (SG).
Кому может быть актуально: Состояния в реестре: Triple Negative Locally Advanced Non-resectable Breast Cancer, HR+, HER2-, Advanced Breast Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)

Обзор

This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.

Вмешательства

Препарат STAR0602
solution, intravenous infusion
Препарат Sacituzumab Govitecan (SG)
intravenous infusion, 10mg/kg

Первичные конечные точки

Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs) [Срок оценки: 21 days following the first dose of STAR0602 + Sacituzumab Govitecan]
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Number of Participants with Adverse Events and Serious Adverse Events [Срок оценки: Up to 3 years]
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of participants with Overall Objective Tumor Responses (ORR) [Срок оценки: Up to 3 years]

Вторичные конечные точки (8)

Phase 1 and 2 (Safety Run-In and Cohort Expansion): Duration of Response (DOR) [Срок оценки: Up to 3 years]
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of Participants with Disease Contral (DCR) [Срок оценки: Up to 3 years]
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Progression Free Survival (PFS) [Срок оценки: Up to 3 years]
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Overall Survival (OS) [Срок оценки: Up to 3 years]
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Maximum Observed Concentration (Cmax) for STAR0602 [Срок оценки: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years]
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Area Under the Concentration Curve (AUC) for STAR0602 [Срок оценки: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years]
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Total Body Clearance (CL) for STAR0602 [Срок оценки: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years]
Phase 1 and 2 (Safety Run-In and Cohort Expansion): Apparent Volume of Distribution (Vd) for STAR0602 [Срок оценки: Cycle 1 and Cycle 3 at predefined intervals (Cycle length = 21 days) up to 3 years]

Критерии участия

Критерии включения

Have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers.
Tumor Type:

mTNBC (Safety Run-in and Cohort A): Progression or recurrence of locally advanced or metastatic TNBC
HR+/HER2- mBC (Safety Run-in and Cohort B): Progression or recurrence of locally advanced or metastatic HR+/HER2- breast cancer
Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:

No concurrent treatment for CNS disease (eg, surgery, radiation, corticosteroids > 10 mg prednisone/day or equivalent); No concurrent leptomeningeal disease or cord compression.

Критерии исключения

History of known autoimmune disease with exceptions of:

Vitiligo
Psoriasis
Atopic dermatitis or other autoimmune skin condition not requiring systemic treatment
History of Graves' disease, now euthyroid for > 4 weeks
Hypothyroidism managed by thyroid replacement
Alopecia
Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs
Adrenal insufficiency well-controlled on replacement therapy
Major surgery or traumatic injury within 8 weeks before first dose of study intervention
Unhealed wounds from surgery or injury
Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study intervention.
Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study intervention administration. Inactivated annual influenza vaccination is allowed.
Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.
Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)
Treatment with >10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study intervention. Exceptions may be made for participants who have had allergic reactions to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed

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

Здоровые добровольцы: Нет