A Study of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors

Официальное название

A Phase I/II, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors

Обзор

For Phase I, to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors. For Phase II, to assess the preliminary anti-tumor activity of IMP in participants with advanced solid tumors.

Вмешательства

• Препарат LM-364 for injection
  Q3W, Intravenous Drip
• Препарат Tislelizumab
  Q3W, Intravenous Drip

Первичные конечные точки

• Incidence of dose-limiting toxicity (DLT) [Срок оценки: 78 weeks]
• Incidence of Treatment-Emergent Adverse Events (AEs) [Срок оценки: 78 weeks]
• Incidence of serious adverse events (SAEs) [Срок оценки: 78 weeks]
• Temperature (Celsius) [Срок оценки: 78 weeks]
• Pulse in BPM(Beat per Minute) [Срок оценки: 78 weeks]
• Blood Pressure in mmHg [Срок оценки: 78 weeks]
• Weight in Kg [Срок оценки: 78 weeks]
• Height in centimeters [Срок оценки: 78 weeks]
• Blood Routine examination -> Complete Blood Count [Срок оценки: 78 weeks]
• Urine Routine examination ->Urinalysis [Срок оценки: 78 weeks]

Вторичные конечные точки (12)

• Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) [Срок оценки: 130 weeks]
• PK Parameter:Time of Maximum Observed Concentration (Tmax) [Срок оценки: 130 weeks]
• PK Parameter: Area Under the Concentration-time Curve (AUC) [Срок оценки: 130 weeks]
• PK Parameter: Steady State Maximum Concentration (Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss) [Срок оценки: 130 weeks]
• PK Parameter: Steady State Minimum Concentration (Cmin,ss) [Срок оценки: 130 weeks]
• PK Parameter: Systemic Clearance at Steady State (CLss) [Срок оценки: 130 weeks]
• PK Parameter: Accumulation Ratio (Rac) [Срок оценки: 130 weeks]
• PK Parameter: Elimination Half-life (t1/2) [Срок оценки: 130 weeks]
• PK Parameter: Volume of Distribution at Steady-State (Vss) [Срок оценки: 130 weeks]
• PK Parameter: Degree of Fluctuation (DF) [Срок оценки: 130 weeks]
• Immunogenicity testing->Anti-Drug Antibody test [Срок оценки: 130 weeks]
• Objective Response Rate (ORR) [Срок оценки: 130 weeks]

Критерии участия

Критерии включения

• Participants who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
• Participants must be ≥18 years or the legal age of consent at the time of signing the ICF.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Life expectancy ≥ 3 months.
• Adequate organ and bone marrow function as defined by protocol.
• Participants who are able to communicate well with investigators and understand and adhere to the requirements of this study.

Критерии исключения

• Participant in any other clinical trial within 28 days prior to 1st dosing of LM-364.
• Any adverse event from prior anti-tumour therapy has not yet recovered to ≤ grade 1 of CTCAE v6.0.
• Participants with uncontrolled tumour-related pain.
• Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-364.
• Participants who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-364.
• Participants who have severe cardiovascular disease.
• Participants who have uncontrolled or severe illness.
• Participants who have a history of immunodeficiency disease.
• Participants with a known history of autoimmune disease.
• Participants who have other active malignancies which are likely to require the treatment.
• Child-bearing potential female who have positive results in pregnancy test or are lactating.
• Participants who have psychiatric illness or disorders that may preclude study compliance.
• Participants who is judged as not eligible to participate in this study by the investigator.

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

Австралия · 3 центра

• Macquarie University — North Ryde
• Cancer Care Wollongong Hospital — Wollongong
• Icon Cancer Centre South Brisbane — Brisbane

Идентификаторы

NCT: NCT07694765 · LM364-01-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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