First in Human Study of TORL-1-23 in Participants With Advanced Cancer

Официальное название

A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer

Обзор

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer

Вмешательства

• Препарат TORL-1-23
  antibody drug conjugate (ADC)

Первичные конечные точки

• Incidence and severity of adverse events and serious adverse events [Срок оценки: up to 2 years]
• Maximum Tolerated Dose (MTD) [Срок оценки: 28 Days]
• Recommended Phase 2 Dose (RP2D) [Срок оценки: up to 2 years]

Вторичные конечные точки (12)

• Objective Response Rate (ORR) [Срок оценки: up to 2 years]
• Duration of Response (DOR) [Срок оценки: up to 2 years]
• Progression Free Survival (PFS) [Срок оценки: up to 2 years]
• Time to Response (TTR) [Срок оценки: up to 2 years]
• 1 Year Overall Survival (1YOS) [Срок оценки: 1 year]
• 2 Year Overall Survival (2YOS) [Срок оценки: 2 years]
• Number of anti-drug antibody (ADA) Positive Participants [Срок оценки: up to 2 years]
• Maximum Serum Concentration of TORL-1-23 (Cmax) [Срок оценки: 21 days]
• Minimum Serum Concentration of TORL-1-23 (Cmin) [Срок оценки: 21 days]
• Maximum Serum Concentration of TORL-1-23 at Steady State (Cmax,ss) [Срок оценки: 63 days]
• Minimum Serum Concentration of TORL-1-23 at Steady State (Cmin,ss) [Срок оценки: 63 days]
• Time of Maximum Serum Concentration of TORL-1-23 (Tmax) [Срок оценки: 21 days]

Критерии участия

Критерии включения

• Advanced solid tumor
• Measurable disease, per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate organ function

Критерии исключения

• Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
• Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-1-23
• Progressive or symptomatic brain metastases
• Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
• History of significant cardiac disease
• History of myelodysplastic syndrome (MDS) or AML
• History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
• If female, is pregnant or breastfeeding

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

США · 9 центров

• Providence Medical Foundation — Fullerton
• UCLA - JCCC Clinical Research Unit — Los Angeles
• University of Kentucky Medical Center — Lexington
• University of Minnesota — Minneapolis
• Mayo Clinic in Rochester — Rochester
• Memorial Sloan Kettering Cancer Center — New York
• Cleveland Clinic — Cleveland
• Sarah Cannon Research Institute Texas Oncology — Tyler
• … и ещё 1 центр

South Korea · 5 центров

• St. Vincent's Hospital, The Catholic University of Korea — Suwon
• Seoul National University Hospital — Seoul
• Severance Hospital — Seoul
• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT05103683 · TORL123-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗