A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

Официальное название

A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

Обзор

This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.

Вмешательства

• Препарат YL201
  YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.
• Препарат Atezolizumab
  Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle

Первичные конечные точки

• Nature and Frequency with Dose-Limiting Toxicities (DLTs) [Срок оценки: 21 days]
• Adverse Events [Срок оценки: First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)]

Вторичные конечные точки (9)

• ORR [Срок оценки: Up to approximately 3 years]
• DOR [Срок оценки: Up to approximately 3 years]
• PFS [Срок оценки: Up to approximately 3 years]
• OS [Срок оценки: Up to approximately 3 years]
• AUC [Срок оценки: Up to approximately 3 years]
• CL [Срок оценки: Up to approximately 3 years]
• Vss [Срок оценки: Up to approximately 3 years]
• t1/2 [Срок оценки: Up to approximately 3 years]
• Cmax [Срок оценки: Up to approximately 3 years]

Критерии участия

Критерии включения

1.18 years of age or older. 2. Histologically or cytologically confirmed diagnosis of ES-SCLC 3. Eastern Cooperative Oncology Group performance status of 0 or 1 4. Adequate hematologic and end-organ function

Критерии исключения

• No prior systemic anti-cancer treatment for ES-SCLC
• No prior treatment targeting B7H3 or topoisomerase I inhibitor
• No clinically active brain metastases or spinal cord compression
• No current or history of interstitial lung disease (ILD)/ pneumonitis
• No clinically significant cardiovascular disease (eg, New York Heart Association class II to IV congestive heart failure)

Other protocol-defined inclusion/ exclusion criteria may apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 10 центров

• Site 2013 — Badajoz
• Site 2014 — Barcelona
• Site 2003 — Barcelona
• Site 2002 — Madrid
• Site 2005 — Madrid
• Site 2004 — Madrid
• Site 2011 — Madrid
• Site 2010 — Manresa
• … и ещё 2 центра

США · 4 центра

• Site 1001 — Washington D.C.
• Site 1004 — Louisville
• Site 1005 — Houston
• Site 1002 — Fairfax

Польша · 3 центра

• Site 1802 — Otwock
• Site 1804 — Poznan
• Site 1801 — Przemyśl

Италия · 2 центра

• Site 1703 — Meldola
• Site 1702 — Ravenna

Бельгия · 1 центр

• Site 1201 — Namur

Румыния · 1 центр

• Site 1901 — Craiova

Великобритания · 1 центр

• Site 2201 — London

Идентификаторы

NCT: NCT07407933 · YL201-INT-102-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗