A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer

Обзор

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer. For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).

Вмешательства

• Препарат TORL-4-500
  antibody drug conjugate

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-4-500 (Cmax) [Срок оценки: 21 days]
• Minimum Serum Concentration of TORL-4-500 (Cmin) [Срок оценки: 21 days]
• Maximum Serum Concentration of TORL-4-500 at Steady State (Cmax,ss) [Срок оценки: 63 days]
• Minimum Serum Concentration of TORL-4-500 at Steady State (Cmin,ss) [Срок оценки: 63 days]
• Time of Maximum Serum Concentration of TORL-4-500 (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-4-500
• 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 · 8 центров

• Mayo Clinic Phoenix — Phoenix
• Providence Medical Foundation — Fullerton
• UCLA - JCCC Clinical Research Unit — Los Angeles
• Torrance Memorial Physician Network — Torrance
• Mayo Clinic Jacksonville — Jacksonville
• Florida Cancer Specialists Lake Nona Drug Development Unit — Orlando
• Mayo Clinic Rochester — Rochester
• Virginia Cancer Specialists — Lexington

Канада · 2 центра

• University Health Network, Princess Margaret Cancer Centre — Toronto
• McGill University Health Centre — Montreal

Идентификаторы

NCT: NCT06005740 · TORL4500-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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