UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies

Официальное название

A Phase Ia/Ib, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic of UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies

Обзор

This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed/refractory B-cell malignancies.

Вмешательства

• Препарат UBX-303061
  UBX-303061 oral dosage

Первичные конечные точки

• Number of subjects with Protocol Specified Dose-Limiting Toxicities [Срок оценки: 28-days]
• To establish the maximum tolerated dose and/or recommended Phase 1b dose(s) [Срок оценки: Up to End of Treatment (up to 9 months)]
• Number of subjects with dose interruptions, reductions, and doses administered [Срок оценки: Up to End of Treatment (up to 9 months)]

Вторичные конечные точки (6)

• To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response [Срок оценки: Up to End of Treatment (up to 9 months)]
• To assess genetic markers including but not limited to BTK, PLCG2, MYD88 [Срок оценки: Up to End of Treatment (up to 9 months)]
• To assess Cmin [Срок оценки: 28-days]
• To assess tmax [Срок оценки: 28-days]
• To assess AUC [Срок оценки: 28-days]
• To assess Cmax [Срок оценки: 28-days]

Критерии участия

Критерии включения

• Capable of giving signed informed consent
• Age ≥18 years
• ECOG performance status ≤2.
• Phase Ia (dose-escalation part only): Subjects with relapsed and/or refractory B-cell malignancies (CLL/SLL, DLBCL, FL, MCL, WM or MZL) who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion.
• Phase Ib (dose-expansion only): Subjects with relapsed and/or refractory B-cell malignancies who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion, and fit into one of the following groups: CLL/SLL or DLBCL or MCL or FL, WM, MZL
• All subjects must have evaluable or measurable disease based on the appropriate tumor type criteria
• Adequate organ and bone marrow function

Критерии исключения

• For subjects with lymphoma:

• Systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, before the first dose of study treatment.
• Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.
• Unconjugated monoclonal antibody therapies <6 weeks before the first dose of study treatment.
• Subjects that have undergone autologous stem cell rescue within 100 days prior to the first dose of study treatment.
• Subjects that have undergone allogeneic stem cell transplant within 6 months prior to the first dose of study treatment.
• Subjects with active graft-versus-host disease (GVHD) or on anti-GVHD treatment or prophylaxis.
• History of chimeric antigen receptor T cell (CAR-T) therapy within 100 days prior to start of study drug.
• Any immunotherapy within 4 weeks of first dose of study drug.
• The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is <5 times the t1/2 of the previously administered agent(s).
• Previously exposed to BTK degradation therapy
• Malignant disease, other than that being treated in this study.
• Radiotherapy within 2 weeks of the first dose of study treatment
• Known hypersensitivity to BTK degraders or any of the ingredients.
• Impaired cardiac function or clinically significant cardiac disease
• Subjects with history of severe bleeding disorders and known/suspected other autoimmune disease
• Major surgery within 4 weeks of the first dose of study treatment

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

Польша · 4 центра

• MICS Centrum Medyczne Toruń — Torun
• Pratia, MTZ Clinical Research — Warsaw
• Pratia, Oncology Katowice — Katowice
• AidPort — Grodzisk Wielkopolski

South Korea · 4 центра

• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul
• The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul
• The Catholic University of Korea, Yeouido St. Mary's Hospital — Seoul

США · 3 центра

• University of Michigan — Ann Arbor
• Gabrail Cancer Center — Canton
• MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT06590961 · UBX-303-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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