Study of ABO2102 in KRAS-Mutated Solid Tumors

Официальное название

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of ABO2102 in Participants With KRAS Mutant Solid Tumors

Обзор

This is a multicenter, open-label Phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as preliminary anti-tumor activity of ABO2102 as monotherapy and in combination among participants with solid tumors with KRAS mutations.

Вмешательства

• Препарат ABO2102 Injection
  mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
• Препарат Sintilimab injection
  Anti-PD-1 antibody, administered intravenously

Первичные конечные точки

• Part I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab [Срок оценки: 28 days after the first dose of study treatment]
• Part I: Incidence and severity of adverse events [Срок оценки: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy]
• Part II: ORR evaluated by investigators according to RECIST v1.1 criteria [Срок оценки: from the first dose of study treatment to up to 3 years]
• Part II: PFS evaluated by investigators according to RECIST v1.1 criteria [Срок оценки: from the first dose of study treatment to up to 3 years]

Критерии участия

Критерии включения

• ≥18 years of age at time of informed consent.
• Have a genetically tested report confirmed by the investigator or complete genetic testing during the screening period, with evidence of harboring any of required KRAS mutations
• Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors.
• According to RECIST v1.1, at least one measurable lesion is required.
• No severe hematological, hepatic, renal or coagulation dysfunction; laboratory test results during the screening period must meet the respective criteria specified in the study protocol.
• Females of childbearing potential and males who are involved in heterosexual activity must agree to practice highly effective contraception.

Критерии исключения

• Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix.
• Has known symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local CNS-directed therapy .
• Received KRAS cancer vaccine before.
• History of severe (≥ Grade 3) hypersensitivity reactions to immunotherapy.
• History of allogeneic organ transplantation or graft-versus-host disease (GVHD).
• Any active infection (except for hepatitis virus infection) requires systemic treatment.
• Absence of spleen
• Known psychiatric disorder or drug abuse that may interfere with the trial requirements
• Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study.
• Other conditions that Investigators consider inappropriate for enrollment.

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 · 1 центр

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07455617 · ABO2102-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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