Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed/Refractory B-Cell Lymphoma

Официальное название

A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ISM8207 Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-Lymphoid Malignancies

Обзор

The goal of this clinical trial is to study ISM8207 in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma. The primary objective is to evaluate the safety and tolerability of ISM8207 orally administered in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma

Вмешательства

• Препарат ISM8207
  Pharmaceutical formulation: Capsules Mode of Administration: Oral

Первичные конечные точки

• Incidence of dose-limiting toxicity (DLT) events [Срок оценки: 31 days]
• Incidence and severity of adverse events (AEs) [Срок оценки: Approximately 2 years]
• Recommended phase 2 dose (RP2D) [Срок оценки: 31 days]

Вторичные конечные точки (12)

• objective response rate (ORR) [Срок оценки: Approximately 2 years]
• best objective response (BOR) [Срок оценки: Approximately 2 years]
• duration of response (DoR) [Срок оценки: Approximately 2 years]
• disease control rate (DCR) [Срок оценки: Approximately 2 years]
• progression-free survival (PFS) [Срок оценки: Approximately 2 years]
• 6-month overall survival (OS) rates [Срок оценки: Approximately 2 years]
• 1-year overall survival (OS) rates [Срок оценки: Approximately 2 years]
• maximum observed concentration (Cmax) [Срок оценки: Approximately 2 years]
• time of maximum observed concentration (Tmax) [Срок оценки: Approximately 2 years]
• area under the concentration-time curve (AUC) [Срок оценки: Approximately 2 years]
• terminal half-life (t1/2) [Срок оценки: Approximately 2 years]
• apparent clearance (CL/F) [Срок оценки: Approximately 2 years]

Критерии участия

Критерии включения

• Male or female participants with age ≥18 years at the time of signing the informed consent.
• Advanced solid tumors: Histologically confirmed advanced or metastatic solid tumors who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists.

B-cell lymphoma: Histologically confirmed B-cell lymphoma who had received at least one prior line of standard therapy and were relapsed after or refractory to the standard therapy.

• Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or Lugano 2014.
• ECOG PS (Eastern Cooperative Oncology Group Performance Status)≤1.
• Life expectancy of ≥12 weeks as judged by the investigator.
• Adequate organ function as determined by medical assessment.
• Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.
• Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception during the treatment period and for 90 days after the last dose of ISM8207.

Критерии исключения

• Prior treated with other QPCTL, CD47 or SIRPα inhibitors.
• Burkitt lymphoma/leukemia, plasma cell myeloma, plasmablastic lymphoma.
• Participation in other therapeutic clinical studies within 28 days or 5 half- lives (whichever is shorter) prior to first dose of study treatment.
• Anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, or other anti-tumor therapy) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment.
• Previous allogeneic stem cell transplantation or autologous stem cell. transplantation within 3 months prior to first receiving study treatment.
• Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia).
• Received antitumor steroid therapy within 7 days prior to the first study treatment administration.
• A serious illness or medical condition(s)

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

Китай · 4 центра

• Beijing Cancer Hospital — Пекин
• The First Affiliated Hospital of Nanchang University — Nanchang
• Shanghai Jiao Tong University School of Medicine-Ruijin Hospital — Шанхай
• Tianjin Medical University Cancer Institute&Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06445517 · ISM8207_101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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