A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors

Обзор

The purpose of this trial is to find the maximum tolerated and recommended Phase 2 dose of KUP-101A and to evaluate its safety and tolerability. Additionally, pharmacokinetics and pharmacodynamics will be assessed, and first data on KUP-101A's efficacy in patients with advanced solid tumors will be obtained.

Вмешательства

• Препарат KUP-101A
  Intravenous infusion of KUP-101A

Первичные конечные точки

• Proportion of patients with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and related TEAEs [Срок оценки: From enrollment until three months after last dose administration]
• Proportion of patients with dose-limiting toxicities (DLTs) [Срок оценки: From start of treatment until one week after last dose administration.]
• Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results [Срок оценки: From enrollment until three months after last dose administration]
• Incidence of abnormal clinical findings in 12-lead ECG parameters and vital signs [Срок оценки: From enrollment until three months after last dose administration]

Вторичные конечные точки (5)

• Area Under the Concentration time Curve from Time 0 Extrapolated to Infinity [Срок оценки: up to 3 weeks]
• Maximum Observed Concentration [Срок оценки: up to 3 weeks]
• Time of the maximum observed concentration [Срок оценки: up to 3 weeks]
• Apparent terminal elimination half-life [Срок оценки: up to 3 weeks]
• Change from baseline in cytokine levels [Срок оценки: From enrollment until three months after last dose administration]

Критерии участия

Критерии включения

• Histologically confirmed cancer with evidence of advanced disease for which no other standard treatment is available
• ECOG Performance status of 0 to 2
• Adequate hematological, renal, and hepatic organ function

Критерии исключения

• Previous systemic treatment with TLR agonists, with the exception of TLR agonists used as vaccine adjuvants.
• Known additional malignancy that is progressing or requires active treatment
• Diagnosis of immunodeficiency
• Active autoimmune disease not caused by prior anticancer treatment that required systemic immunosuppressive treatment in the past 2 years
• Active autoimmune disease caused by prior anticancer treatment, unless currently controlled by replacement therapy only.
• Any kind of leukemia
• Previously received an organ transplant (other than corneal transplants) or hematopoietic stem cell transplantation
• Known active central nervous system metastases and/or carcinomatous meningitis
• Cerebral vascular event within 6 months before Screening
• Unstable cardiopulmonary status defined by uncontrolled congestive heart failure of New York Heart Association Grade III or IV, unstable angina, or myocardial infarction within 6 months before Screening
• High grade ocular disease such as uncontrolled glaucoma

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 2 центра

• Universitätsklinikum Würzburg — Würzburg
• Fachklinik Hornheide — Münster

Идентификаторы

NCT: NCT07600476 · KUP-CT01 · 2025-522402-21-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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