A Phase I Study of SHR-3836 in Patients With Multiple Myeloma

Официальное название

An Open-label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3836 in Patients With Multiple Myeloma

Обзор

This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-3836 in patients with multiple myeloma (MM).

Вмешательства

• Препарат SHR-3836 administered as multiple doses.
  * In the dose escalation phase, doses are escalated sequentially from low to high levels. * In the dose expansion phase, one or more selected dose levels are further evaluated.

Первичные конечные точки

• Determination of Phase II Dose (RP2D) of SHR-3836 [Срок оценки: 24 months]

Вторичные конечные точки (4)

• Incidence and severity of adverse events (AE) of SHR-3836 [Срок оценки: 24 months]
• Maximum plasma concentration (Cmax) [Срок оценки: 24 months]
• Time to reach Cmax (Tmax) [Срок оценки: 24 months]
• Objective response rate (ORR) [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Age ≥ 18 years, male or female
• Expected survival ≥ 3 months
• ECOG performance status 0 or 1
• Diagnosed with active multiple myeloma per IMWG criteria
• Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy.
• Disease progression or non-response to the most recent therapy
• Measurable disease as defined by serum/urine M-protein or serum free light chain
• Adequate bone marrow, hepatic, renal, and coagulation function
• Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception
• Willing and able to provide written informed consent and comply with study procedures

Критерии исключения

• Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome.
• Central nervous system involvement by tumor.
• History of ≥ Grade 3 CRS with prior T-cell redirecting therapy.
• Requirement for dialysis or plasmapheresis within 14 days prior to study drug.
• Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies).
• Concurrent participation in another clinical study.
• Prior anti-tumor therapy within specified washout periods.
• Major surgery within 28 days prior to informed consent or planned during the study.
• Live attenuated vaccine within 4 weeks prior to first dose or planned during the study.
• Significant comorbidity that in the investigator's judgment would interfere with study participation or safety.
• Active autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo).
• Active infection.
• Known hypersensitivity or contraindication to SHR-3836.

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

Китай · 1 центр

• The First Affiliated Hospital of Soochow University — Сучжоу

Идентификаторы

NCT: NCT07490613 · SHR-3836-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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