A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy

Официальное название

A Phase 1a/b, Open-label, Multicenter, First-in-human, Dose Escalation/Expansion Study With Multiple Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Efficacy of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy

Обзор

The study consists of Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, sequential cohorts of subjects will receive escalating doses of ITC-6146RO to determine maximum tolerated dose (MTD) and/or optimal biological dose (OBD). In Phase 1b, the recommended phase 2 dose (RP2D) chosen from Phase 1a will be evaluated to further investigate safety, tolerability, pharmacokinetic (PK) and anti-tumor efficacy of ITC-6146RO.

Вмешательства

• Препарат ITC-6146RO
  ITC-6146RO will be administered as an intravenous (IV) infusion at protocol-specified dose levels and schedules in Phase 1a (dose escalation) and Phase 1b (dose expansion).

Первичные конечные точки

• Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs) [Срок оценки: Through study completion (Up to 2 years)]
• Phase 1b (Dose Expansion) Incidence of AEs [Срок оценки: Through study completion (Up to 2 years)]

Вторичные конечные точки (12)

• Phase 1a (Dose Escalation) Maximum Tolerated Dose (MTD) or Optimal Biological Dose (OBD) of ITC-6146RO [Срок оценки: Through study completion (Up to 2 years)]
• Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Single-Dose Administration of ITC-6146RO [Срок оценки: Through study completion (Up to 2 years)]
• Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) After Single-Dose Administration of ITC-6146RO [Срок оценки: Through study completion (Up to 2 years)]
• Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration (Cmax) After Single-Dose Administration of ITC-6146RO [Срок оценки: Through study completion (Up to 2 years)]
• Phase 1a (Dose Escalation) Terminal Elimination Half-life (t1/2) After Single-Dose Administration of ITC-6146RO [Срок оценки: Through study completion (Up to 2 years)]
• Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration (Tmax) After Single-Dose Administration of ITC-6146RO [Срок оценки: Through study completion (Up to 2 years)]
• Phase 1a (Dose Escalation) Apparent Clearance (CL) After Single-Dose Administration of ITC-6146RO [Срок оценки: Through study completion (Up to 2 years)]
• Phase 1a (Dose Escalation) Apparent Volume of Distribution (Vz) After Single-Dose Administration of ITC-6146RO [Срок оценки: Through study completion (Up to 2 years)]
• Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Multiple-Dose Administration of ITC-6146RO [Срок оценки: Through study completion (Up to 2 years)]
• Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration at Steady State (Cmax,ss) After Multiple-Dose Administration of ITC-6146RO [Срок оценки: Through study completion (Up to 2 years)]
• Phase 1a (Dose Escalation) Trough Plasma Concentration at Steady State (Ctrough,ss) After Multiple-Dose Administration of ITC-6146RO [Срок оценки: Through study completion (Up to 2 years)]
• Phase 1a (Dose Escalation) Average Plasma Concentration Over the Dosing Interval at Steady State (Cav,τ) After Multiple-Dose Administration of ITC-6146RO [Срок оценки: Through study completion (Up to 2 years)]

Критерии участия

Критерии включения

• Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States)
• Patients must be individuals who have voluntarily agreed to participate in the study after receiving a detailed explanation and fully understanding the nature of the clinical trial, and who have provided written informed consent.
• Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
• Patients must have at least one evaluable or measurable lesion based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). However, for patients with prostate cancer, eligibility will be determined based on Prostate Cancer Working Group 3 (PCWG3)
• Patients who have received standard therapies and have no remaining clinically available approved treatment options.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Estimated life expectancy of ≥ 3 months

Критерии исключения

• Inability to comply with study and follow-up procedures
• Patients with a prior history of anticancer therapy before the first dose
• History of another active malignancy within the past 3 years
• Patients with central nervous system metastases, leptomeningeal disease, or spinal cord compression.
• Patients who are currently participating in a clinical trial or have participated in a clinical trial involving a medical device or investigational product within 28 days prior to the first administration of ITC-6146RO
• Has prior treatment with duocarmycin-containing agents
• Pregnancy, lactation, or breastfeeding
• Known Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) infection with active disease exception of the following conditions.
• Tuberculosis with active disease
• Active infection necessitating systemic therapy
• Prior allogenic bone marrow transplantation or solid organ transplantation
• History of autoimmune disease, treatment with systemic immunosuppressive medications
• Patients with clinically significant pulmonary disease

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07423117 · ITC06P1-P01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗