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Набира участници Фаза 1 NCT06297525

Study of STP938 in Advanced Solid Tumours

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Solid Tumor

Спонсор: Step Pharma, SAS

Налично на: БГ
Обобщение
The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy. The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.
Кой може да участва
Main Inclusion Criteria: * Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization. * Male or female aged ≥ 18 years. * Advanced disease not curable by available therapies and requires systemic therapy. * Histologically confirmed diagnosis of eligible cancer type. * Must have tumor tissue available for biomarker testing. * Measurable disease (Part 1) and measurable disease per RECIST (Part2) * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Life expectancy \> 3 months as assessed by the Investigator. * Adequate organ function (bone marrow, hepatic, renal function and coagulation). * All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment. Main Exclusion Criteria: * Pregnant or breastfeeding females and women of childbearing potential or males unwilling to comply with contraception requirements. * Known active or symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease or a history of spinal cord compression * Active malignancy within 2 years of study enrollment * Prior radiation within 2 weeks of start of therapy. * Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or \<5 half-lives since completion of previous investigational therapy, whichever is shorter. * Uncontrolled intercurrent illness. * Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months. * Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection. * Subjects with corrected QT interval \>470 msec based on averaged triplicate electrocardiogram (ECG) readings at the Screening Visit using the QT interval corrected for heart rate using Fridericia's method (QTcF).
Интервенции
STP938
DRUG
Места на провеждане 7
Франция (1)
Institut Gustave Roussy
Villejuif , Paris
Великобритания (3)
The Beatson Institute for Cancer Research
Glasgow , Glasgow
University College London
London
The Christie
Manchester
САЩ (3)
Mary Crowley Cancer Research Center
Dallas , Texas
Next Oncology
San Antonio , Texas
Comprehensive Hematology Oncology, LLC
St. Petersburg , Florida
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
02.08.2024
Крайна дата
01.05.2027
Регистрационен номер
NCT06297525
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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