A Study for HSK39775 in Participants With Solid Tumors

Официальное название

A Phase I/II Study to Assess the Safety, Tolerability, PK/PD, and Preliminary Efficacy of HSK39775 Tablet Monotherapy in Participants With Advanced Solid Malignancies

Обзор

This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

Вмешательства

• Препарат HSK39775 Monotherapy
  HSK39775 will be administered orally once daily

Первичные конечные точки

• AE/SAE [Срок оценки: From time of informed consent to 28 days post last dose or start of other anti-cancer therapies]
• DLT [Срок оценки: From the start of first dose to the end of Cycle1(each cycle is 28 days)]
• MTD/MAD [Срок оценки: From the start of first dose to the end of Cycle1(each cycle is 28 days)]

Вторичные конечные точки (9)

• Maximum Plasma Concentration [Cmax] [Срок оценки: At predefined intervals throughout the treatment period(approximately 12 weeks)]
• Area Under Curve[AUC] [Срок оценки: At predefined intervals throughout the treatment period(approximately 12 weeks)]
• Time to maximum observed concentration [Tmax] [Срок оценки: At predefined intervals throughout the treatment period(approximately 12 weeks)]
• Elimination half-life [t1/2] [Срок оценки: At predefined intervals throughout the treatment period(approximately 12 weeks)]
• Overall Response Rate (ORR) per RECIST V1.1 [Срок оценки: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]]
• Progression Free Survival [Срок оценки: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]]
• Time To Response [Срок оценки: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]]
• Disease Control Rate [Срок оценки: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]]
• Best percentage change in target lesion [Срок оценки: From Screening to confirmed progressive disease or date of death from any cause, whichever came first[approximately 1 year]]

Критерии участия

Критерии включения

• Age 18 years or older at screening
• Histological or cytological confirmation of advanced malignancy, have failed or intolerant to the standard-of-care treatment or no standard therapy is recognized or standard therapy is unavailable
• Eastern Cooperative Oncology Group performance status 0 or 1
• Patients must have evaluable disease as defined
• Life expectancy of ≥ 12 weeks
• Adequate organ and bone marrow function per protocol
• Female patients who are women of childbearing potential with confirmed of a negative pregnancy test within 7 days prior to the first dose and agreement to the use of effective contraceptive method at the same time during study treatment period and for up to 6 months after the last dose of study treatment. Male patients must be willing to use effective contraception during the study treatment period and for up to 6 months after the last dose of study treatment
• Written informed consent must be obtained

Критерии исключения

• Known allergies to HSK39775 or its excipients
• Prior anticancer treatment is ineligible per protocol
• Subjects who have had continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent within 4 weeks prior to the first dose of study treatment
• Subjects who have had live vaccine within 4 weeks prior the first dose of study treatment
• Currently participating in a study of another investigational agent or device
• Subjects who have had received another agent with same target
• Subjects who have not recovered (to grade ≤1 or baseline) from toxicities related to prior therapies
• Subjects who have had received drugs that may have drug-drug interaction potential within 4 weeks or 5 half-lives prior to the first dose of study treatment
• Subjects who have had received major surgery within 4 weeks prior the first dose of study treatment
• Central nervous system metastases associated with neurological symptoms
• Active hepatitis B or hepatitis C infection
• A history of immunodeficiency
• Clinically relevant cardiovascular disease as delined by protocol
• Inability to swallow the formulated product or impairment of GI function or disease that may significantly alter the absorption of study drug
• A female patient who is pregnant or lactating
• Other conditions, in investigator's opinion, not suitable to participate in the clinical study

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

Китай · 1 центр

• Fundan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06314373 · HSK39775-101/201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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