A Study of YL242 in Subjects With Advanced Solid Tumors

Официальное название

A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors.

Обзор

This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant tumors.

Вмешательства

• Препарат YL242
  The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes.
• Препарат YL242; Pembrolizumab
  The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. Pembrolizumab will be administered subsequent to YL242.
• Препарат YL242; 5-FU; LV
  The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. The initial dose of YL242 will be infused IV into each patient for 90±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL242 will be infused IV into each patient for 60±10 minutes. LV and 5-FU will be sequentially administered following YL242.
• Препарат YL242; Pembrolizumab; 5-FU
  The YL242 drug product is provided as a lyophilized powder containing 200 mg of YL242 in a glass vial. YL242 will be administered via Intravenous (IV) Infusion. Pembrolizumab and 5-FU will be administered in sequence after YL242.

Первичные конечные точки

• Objective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6) [Срок оценки: Approximately within 36 months]
• Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Baseline up to 42 days post last patients last dose, approximately within 36 months]

Вторичные конечные точки (6)

• Area Under the Serum Concentration Time Curve (AUC) of YL242 [Срок оценки: Approximately within 36 months]
• Maximum Plasma Concentration (Cmax) of YL242 [Срок оценки: Approximately within 36 months]
• Time to Maximum Plasma Concentration (Tmax) of YL242 [Срок оценки: Approximately within 36 months]
• Incidence of anti-YL242 antibody [Срок оценки: Approximately within 36 months]
• Terminal Elimination Half-life (t1/2) of Serum YL242 [Срок оценки: Approximately within 36 months]
• Disease Control Rate (DCR) [Срок оценки: Approximately within 36 months]

Критерии участия

Критерии включения

• Aged ≥18 years.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
• Adequate organ and bone marrow function
• Tumor type:

Part 1-3: Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy

Part 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy;

Part 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy

Part 6: advanced or metastatic HER2-negative G/GEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy

Критерии исключения

• Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor
• Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases
• Clinically significant concomitant pulmonary disease
• A history of leptomeningeal carcinomatosis or carcinomatous meningitis
• Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results

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

США · 7 центров

• US-201 — New Haven
• US-202 — Sarasota
• US-204 — Boston
• US-206 — Grand Rapids
• US-205 — Nashville
• US-203 — Houston
• US-207 — San Antonio

Австралия · 5 центров

• AUS-101 — Liverpool
• AUS-102 — Darlinghurst
• AUS-104 — Fitzroy
• AUS-103 — Heidelberg
• AUS-105 — Nedlands

Китай · 3 центра

• CN-303 — Харбин
• CN-301 — Шанхай
• CN-302 — Ханчжоу

Идентификаторы

NCT: NCT07197827 · YL242-INT-101-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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