A Phase Ia/Ib Study of HW221043 in Participants With Advanced Solid Tumors

Официальное название

A Phase I Study Evaluating the Safety, Pharmacokinetics, and Efficacy of HW221043 Tablets in Participants With Advanced Solid Tumors

Обзор

This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HW221043 tablets in participants with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).

Вмешательства

• Препарат HW221043 Tablets
  HW221043 Tablets for oral administration at specified doses on scheduled days.

Первичные конечные точки

• Adverse Events (AE) or Serious Adverse Events (SAE) [Срок оценки: 2 years]
• Dose Limited Toxicity (DLT) [Срок оценки: 2 years]

Вторичные конечные точки (5)

• Maximum Plasma Concentration (Cmax) [Срок оценки: 2 years]
• Area Under the Concentration-Time Curve (AUC) [Срок оценки: 2 years]
• Tmax [Срок оценки: 2 years]
• Objective Response Rate (ORR) [Срок оценки: 2 years to 3 years]
• Progression-Free Survival (PFS) [Срок оценки: 2 years to 3 years]

Критерии участия

Критерии включения

• Men or women ≥18 years old.
• Histologically and/or cytologically confirmed recurrent or metastatic advanced solid tumors.
• Absence of available standard therapy, failure of standard therapy, or ineligibility for standard therapy.
• Survival expectation is ≥12 weeks.
• Adequate major organ function at screening; no blood transfusion or hematopoietic growth factor administration within 14 days prior to screening; and no significant abnormalities in hematology, coagulation profiles, or blood chemistry.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• Presence of at least one measurable target lesion as defined by RECIST 1.1
• Participants are willing to provide tumor tissue samples.
• Participants of childbearing potential must be non-pregnant at screening. Male and female of childbearing potential must agree to use effective methods of contraception throughout the study.
• Participants must have demonstrated a full understanding of the study, voluntarily signed the informed consent form (ICF), and be willing and able to comply with all study procedures and required follow-up visits.

Критерии исключения

• Allergic to HW221043 Tablet or its components.
• Has a treatment history of KIF18A inhibitor.
• Known presence of a recognizable hypermutated phenotype.
• Prior receipt of any unapproved investigational drug or therapy within 28 days before first dose.
• Inadequate washout from prior antitumor therapy.
• Use of any medication that may interfere with the safety conduct of the study within 14 days prior to the first dose (or within at least 5 half-lives of the agent, whichever is longer), or planned use of such medications during the study period.
• Continuous use of systemic corticosteroids within 4 weeks prior to the first dose.
• Live vaccination within 28 days prior to first dose or anticipated during the study.
• Major surgery within 28 days prior to the first dose of the investigational product.
• Major surgical procedure within 28 days prior to first dose.
• History of another active malignancy within 3 years prior to initiation of the investigational product.
• ≥ Grade 2 prior antitumor therapy-related toxicity per CTCAE v6.0 (except abnormalities deemed clinically insignificant).
• Tumor invasion into adjacent vital organs, major vessels, or central nervous system (CNS), or evidence of progressive brain metastases.
• Presence of severe underlying pulmonary disease, severe cardiac/cerebrovascular disease, or clinically significant QTc prolongation.
• Presence of an active infectious disease.
• Diagnosis of an autoimmune disease or presence of an immunodeficient state.
• Inability to swallow oral medications, or uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal dysfunction likely to affect drug absorption.
• History of alcohol abuse or substance abuse.
• Women who are pregnant, breastfeeding, or planning to become pregnant/ breastfeeding during the study.
• Any condition that, in the judgment of the Investigator, would make the participant unsuitable for enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07719920 · HW221043-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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