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Набира участници Фаза 1 NCT07156136

Study of IMC-P115C in Advanced PRAME-Positive Cancers

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: PRAME Positive Cancer HLA-A*02:01-positive

Спонсор: Immunocore Ltd

Налично на: БГ
Обобщение
Phase 1 First-in-human study of the safety and efficacy of IMC-P115C as a single agent and in combination with standard of care (SOC) agents in participants with advanced PRAME positive cancers. IMC-P115C is a half-life extended (HLE) ImmTAC targeting PRAME.
Кой може да участва
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * HLA-A\*02:01-positive * Meeting PRAME-positive tumor testing requirements * Metastatic or unresectable solid tumors * Have received (or be receiving), relapsed from, be refractory to or intolerant of all therapies * Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control Exclusion Criteria: * Symptomatic or untreated central nervous system metastasis * Bowel obstruction, perforation, or fistula formation within 3 months prior to the planned first dose of study treatment * Ongoing ascites or effusion requiring recent drainages * Significant ongoing toxicity from prior anticancer treatment * Out-of-range laboratory values * Clinically significant lung, heart, or autoimmune disease * Ongoing requirement for immunosuppressive treatment * Significant secondary malignancy * Hypersensitivity to study drug or excipients * Pregnant or lactating
Места на провеждане 4
Австралия (1)
Cancer Research South Australia (CRSA)
Adelaide
Франция (1)
UNICANCER - Centre Leon-Berard (CLB)
Lyon
Италия (1)
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan
Испания (1)
Hospital Universitari Vall d Hebron
Barcelona
Технически детайли
Статус
Набира участници
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
07.11.2024
Крайна дата
30.08.2029
Регистрационен номер
NCT07156136
Източник
anzctr
Запитване за медицински туризъм

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