Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors

Официальное название

A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 and/or QL1706 Combination Chemotherapy for the Treatment of CLDN18.2-Positive Advanced Malignant Solid Tumors

Обзор

This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.

Вмешательства

• Препарат QLS31905
  Administered as an intravenous infusion.
• Препарат Oxaliplatin
  130 mg/m2, intravenous infusion, D1, up to 8 cycles.
• Препарат Capecitabine
  1000 mg/m2, oral, bid, D1-D14
• Препарат Gemcitabine
  1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
• Препарат Cisplatin
  25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
• Препарат QL1706
  5 mg/kg, intravenous infusion,D1
• Препарат Chemotherapy drug
  Standard chemotherapy recommended by guidelines.

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: Approximately 24 months]

Вторичные конечные точки (12)

• Safety assessed by Adverse Events (AEs) [Срок оценки: Approximately 24 months]
• Safety assessed by incidence of serious adverse events (SAE) [Срок оценки: Approximately 24 months]
• Number of participants with laboratory value abnormalities [Срок оценки: Approximately 24 months]
• Duration of Response (DOR) [Срок оценки: Approximately 24 months]
• Progression Free Survival(PFS) [Срок оценки: Approximately 24 months]
• Overall Survival (OS) [Срок оценки: Approximately 24 months]
• Maximum concentration (Cmax) [Срок оценки: Approximately 24 months]
• Time of the maximum concentration (Tmax) [Срок оценки: Approximately 24 months]
• Terminal elimination half-life (T1/2) [Срок оценки: Approximately 24 months]
• Clearance (CL) [Срок оценки: Approximately 24 months]
• Apparent volume of distribution during the terminal phase (Vz) [Срок оценки: Approximately 24 months]
• Number of anti-drug antibody (ADA) Positive Participants [Срок оценки: Approximately 24 months]

Критерии участия

Критерии включения

• Subjects voluntarily participate in the study and sign the informed consent form;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Expected survival time ≥ 3 months;
• Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors;
• No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
• Tumor tissue samples determined to be positive for Claudin18.2 by immunohistochemistry (IHC);
• At least one measurable lesion per RECIST v1.1;
• Patients with adequate cardiac, liver, renal function, etc.

Критерии исключения

• History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
• Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
• Known central nervous system metastases;
• Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test; Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
• Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT06446388 · QLS31905-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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