Phase 1 Study of MST-168 in Participants With Advanced Solid Malignant Tumors

Официальное название

A Phase 1, Multiregional, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MST-168, in Participants With Advanced Solid Malignant Tumors

Обзор

A Phase 1, multiregional, open-label study of MST-168 in participants with target-driven advanced solid tumors. The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects, and preliminary efficacy of MST-168 in participants with target-driven advanced solid tumors. MST-168 is an investigational ADC.

Вмешательства

• Биопрепарат MST-168
  MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.

Первичные конечные точки

• Incidence of dose-limiting toxicities (DLT) [Срок оценки: Day 1 - Day 28]
• Incidence and severity of AEs, clinically significant changes from Baseline (pre-dose on D1) through to the EOT in vital signs, laboratory tests, physical examinations, 12-lead ECG, and ECHO/MUGA. [Срок оценки: Through study completion, up to 25 months]

Вторичные конечные точки (12)

• PK parameters for MST-168, total anti-drug antibody and free payload: Tmax [Срок оценки: Day 1 to Day 8]
• PK parameters for MST-168, total anti-drug antibody and free payload: Cmax [Срок оценки: Day 1 to Day 8]
• PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t [Срок оценки: Day 1 to Day 8]
• PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞ [Срок оценки: Day 1 to Day 8]
• PK parameters for MST-168, total anti-drug antibody and free payload: t1/2 [Срок оценки: Day 1 to Day 8]
• PK parameters for MST-168, total anti-drug antibody and free payload: CL [Срок оценки: Day 1 to Day 8]
• PK parameters for MST-168, total anti-drug antibody and free payload: Vss [Срок оценки: Through study completion, up to 24 months]
• PK parameters for MST-168, total anti-drug antibody and free payload: AUCss [Срок оценки: Through study completion, up to 24 months]
• PK parameters for MST-168, total anti-drug antibody and free payload: Css,max [Срок оценки: Through study completion, up to 24 months]
• PK parameters for MST-168, total anti-drug antibody and free payload: Css,min [Срок оценки: Through study completion, up to 24 months]
• Frequencies of ADAs and neutralizing antibodies specific to MST-168. [Срок оценки: Through study completion, up to 24 months]
• Biomarkers: cytokines/chemokines and immune cell phenotypes [Срок оценки: Through study completion, up to 24 months]

Критерии участия

Критерии включения

• Participants are eligible to be included in the study only if all of the following criteria apply:

I1. Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol.

I2. Is at least 18 years of age at the time of signing the ICF.

I3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

I4. Life expectancy ≥ 12 weeks.

I5. Has adequate organ function.

I6. Pregnancy and Contraception: Female participants agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment. Male participants with partners of childbearing potential and female participants of childbearing potential are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from beginning of the study screening until 6 months after receiving the last treatment of MST-168.

I7. Has a pathologically documented advanced/unresectable or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.

Критерии исключения

• Participants are excluded from the study if any of the following criteria apply:

E1. Has untreated brain or CNS metastases or brain/CNS metastases that have progressed \[e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases\]. Participants with previously unstable brain or CNS metastases.

E2. Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of metastatic disease.

E3. Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.

E4. Has known sensitivity to study intervention components or excipients.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07644650 · MST-168-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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