A Study of QLS5133 Monotherapy in Advanced Solid Tumors

Официальное название

A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5133 Monotherapy in Subjects With Advanced Solid Tumors

Обзор

The phase 1/2 clinical study includes three stages: Phase 1 dose escalation, phase 1 PK expansion and phase 2 cohort expansion： * Phase 1: Assesse safety, tolerability, PK, immunogenicity and preliminary efficacy of QLS5133 in advanced solid tumors. Phase 1 dose escalation will use ATD + BOIN, the maximum sample size for each dose group is 12. For Phase 1 PK expansion, 1 to 4 appropriate doses will be selected. After the DLT observation period in the selected dose group up to 12 subjects (including those subjects in the dose escalation stage) can be further enrolled for PK expansion. * Phase 2: Evaluates QLS5133's anti-tumor efficacy in subjects with advanced solid tumors. at least 2 dose groups will be expanded.

Вмешательства

• Препарат QLS5133
  antibody drug conjugate (ADC)

Первичные конечные точки

• Incidence and severity of adverse events and serious adverse events [Срок оценки: up to 2 years]
• Maximum tolerated dose (MTD) [Срок оценки: 28days]
• Recommended Phase 2 Dose (RP2D) [Срок оценки: up to 2 years]
• Objective Response Rate (ORR) [Срок оценки: up to 2 years]

Вторичные конечные точки (12)

• Maximum Serum Concentration of QLS5133 (Cmax) [Срок оценки: 21 days]
• Maximum Serum Concentration of QLS5133 at Steady State (Cmax,ss) [Срок оценки: 63 days]
• Minimum Serum Concentration of QLS5133 at Steady State (Cmin,ss) [Срок оценки: 63 days]
• Time of Maximum Serum Concentration of QLS5133 (Tmax) [Срок оценки: 21 days]
• Terminal Half-life (T1/2) of Serum QLS5133 [Срок оценки: 63 days]
• Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUC0-t) for QLS5133 [Срок оценки: 21 days]
• Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUC0-∞) for QLS5133 [Срок оценки: 63 days]
• Apparent Volume of Distribution (Vd) of QLS5133 [Срок оценки: 63 days]
• Clearance (CL) of QLS5133 [Срок оценки: 63 days]
• Duration of Response (DOR) [Срок оценки: up to 2 years]
• Progression Free Survival (PFS) [Срок оценки: up to 2 years]
• Time to Progression (TTP) [Срок оценки: 1 years]

Критерии участия

Критерии включения

• Aged ≥ 18 years on the day of signing the ICF, male or female;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0 or 1;
• Measurable disease, per RECIST v1.1;
• Adequate organ function;
• Recover from all reversible AEs from previous anti-tumor treatment (i.e., Grade ≤ 1, according to NCI-CTCAE v5.0), excluding alopecia (any grade) and Grade ≤ 2 neuropathy peripheral, or who experience other abnormalities that are not clinically significant or toxicities judged to have no risk by the investigator;
• Left ventricular ejection fraction (LVEF) ≥ 50%;

Критерии исключения

• Previous treatment with drugs targeting CDH6 (including ADCs), or any drug containing topoisomerase I inhibitors (including ADCs);
• Large and uncontrollable pleural, pericardial or abdominal effusion before the first dose (those who are stable for at least 2 weeks after drainage can be enrolled);
• Progressive or symptomatic brain metastases;
• Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before the first dose
• History of significant cardiac disease, or poorly controlled diabetes mellitus;
• History of recurrent autoimmune diseases;
• History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
• History of other active malignant tumors within 3 years before signing the informed consent form;
• If female, is pregnant or breastfeeding;
• Be allergic to any component of QLS5133 or its excipients.

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 · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07061639 · QLS5133-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗