First in Human Study of TUB-030 in Patients With Advanced Solid Tumors

Официальное название

A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)

Обзор

The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are: To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose. Participants will: Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms

Вмешательства

• Препарат TUB-030
  A complete treatment cycle is defined as 21 calendar days. TUB-030 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle

Первичные конечные точки

• Determination of MTD [Срок оценки: From enrollment until 30 days after last study drug]

Вторичные конечные точки (8)

• Number of patients with Adverse Events (AE) [Срок оценки: From enrollment until 30 days after last study drug]
• Maximum concentration (Cmax) [Срок оценки: From enrollment until 30 days after last study drug]
• Trough concentration (Cmin) [Срок оценки: From enrollment until 30 days after last study drug]
• The time taken to reach the maximum concentration (Tmax) [Срок оценки: From enrollment until 30 days after last study drug]
• Area Under Curve (AUC) [Срок оценки: From enrollment until 30 days after last study drug]
• Half life (T1/2) [Срок оценки: From enrollment until 30 days after last study drug]
• Determination of immunogenicity [Срок оценки: From enrollment until 30 days after last study drug]
• Determination of efficacy [Срок оценки: From enrolment until 30 days after last study drug.]

Критерии участия

Критерии включения

• Male or non-pregnant, non-breastfeeding female aged 18 years or older
• Adequate organ function
• Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1
• AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.
• For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.
• For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D1. For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D1.
• Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.
• Eastern Cooperative Oncology Group (ECOG) 0-1.
• Have a life expectancy of >12 weeks for disease-related mortality, as evaluated by the INV.
• In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent
• Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.
• Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.

Критерии исключения

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 12 центров

• Yale Cancer Center — New Haven
• University of Miami — Miami
• Dana Farber Cancer Institute — Boston
• Mayo Clinic — Rochester
• Washington University — St Louis
• Mount Sinai — New York
• Cleveland Clinic — Cleveland
• Ohio State University — Columbus
• … и ещё 4 центра

Румыния · 2 центра

• Arensia Exploratory Medicine — Bucharest
• Arensia Exploratory Medicine — Cluj-Napoca

Канада · 1 центр

• Princess Margaret — Toronto

Испания · 1 центр

• Clinica Uni de Navara — Madrid

Идентификаторы

NCT: NCT06657222 · 5-STAR 1-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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