Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors

Официальное название

A Phase I, First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0508 Monotherapy and Combination Therapy in Adult Participants With Locally Advanced/Metastatic Solid Tumors

Обзор

This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK/PD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic solid tumors.

Вмешательства

• Препарат SIM0508 Tablets
  Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.
• Препарат SIM0508 in combination with olaparib
  Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.
• Препарат SIM0508 in combination with olaparib
  Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0508 combination with olaparib established from SIM0508 combination dose escalation.

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: At the end of Cycle 1 (each cycle is 28 days)]

Критерии участия

Критерии включения

• Voluntary participation and signature of informed consent form.
• Participants with histologically confirmed ovarian cancer, prostate cancer,breast cancer , or pancreatic cancer.
• ECOG score of 0 or 1.
• Expected survival ≥ 12 weeks.

Критерии исключения

• Active hepatitis B (HBsAg or HBcAb positive and HBV DNA≥1×104 copies/mL or≥2000 international unit \[IU\]/mL) or hepatitis C (HCV antibody positive and HCV RNA≥ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the study.
• Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
• Participants unable to swallow study drug and participants with gastrointestinal disorders likely to interfere with absorption of the study drug.
• Toxicities from previous anticancer therapies have not resolved (e.g to ≤ Grade 1).
• Pregnant or nursing (lactating) women; other women of childbearing potential, unless the blood pregnancy test within 7 days of first dose of study drug is negative, and participants agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 or olaparib, whichever comes later.
• Male partinipants with female partners of reproductive potential, unless they agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 and 90 days after the last dose of olaparib, whichever comes later.

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 · 2 центра

• Fudan University Shanghai Cancer Center — Шанхай
• Chongqing Cancer Hospital — Чунцин

Идентификаторы

NCT: NCT06686745 · SIM0508-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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