A Study of DS3610a in Participants With Advanced Solid Tumor

Официальное название

A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS3610a in Participants With Advanced Solid Tumor

Обзор

This study is designed to assess the safety, tolerability, and efficacy of DS3610a, given as a single agent to participants with advanced or metastatic solid tumors.

Подробное описание

This is a dose escalation study for participants with advanced or metastatic solid tumors. The primary objective of the study is to determine the Recommended Dose for Expansion (RDE), and to evaluate the safety, tolerability, PK, and preliminary efficacy of DS3610a in solid tumors.

Вмешательства

• Препарат DS3610a
  Participants will receive DS3610a at the target dose. Treatment will continue until radiographic disease progression, as determined by the investigator, or until another reason for discontinuation of trial intervention occurs.

Первичные конечные точки

• Dose Limiting Toxicities [Срок оценки: From first dose, up to approximately 24 months]

Вторичные конечные точки (2)

• Area Under the Blood Concentration-time Curve During Dosing Interval [Срок оценки: From baseline to postbaseline, up to approximately 36 months]
• Antidrug Antibody Prevalence [Срок оценки: From baseline to postbaseline, up to approximately 36 months]

Критерии участия

Критерии включения

• Sign and date the main ICF, prior to the start of any trial-specific procedures.
• Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is >18 years old).
• Relapsed from, refractory to, or intolerant to appropriate therapies (eg, SoC) to provide clinical benefit for their condition as assessed by their physician and/or investigator.
• Is willing and able to provide an adequate pretreatment tissue sample prior to trial intervention or archival tumor tissue sample.
• Has measurable disease based on local CT/MRI imaging as assessed by the investigator per RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention.

Критерии исключения

\*Inadequate washout period before initiation of trial intervention, defined as: Major surgery: ≤4 weeks (or ≤2 weeks for low-invasive cases) Curative radiation therapy: ≤4 weeks Chemotherapy, Ab-based anticancer therapy, immunotherapy: ≤4 weeks Small molecules (eg, tyrosine kinase inhibitors): ≤2 weeks or 5 half-lives, whichever is longer Nitrosoureas: ≤6 weeks

• Has known symptomatic CNS metastases, leptomeningeal disease, or cord compression. Note: Asymptomatic or adequately treated CNS metastases are not exclusionary provided that, in the opinion of the investigator, the participant is neurologically stable. MRI/CT of the brain is required for all participants during SCR Period
• Uncontrolled or clinically significant cardiovascular disease, including the following:

• Myocardial infarction within 6 months prior to SCR.
• Uncontrolled angina pectoris within 6 months prior to SCR.
• New York Heart Association (NYHA) Class III or IV CHF.
• LVEF ≤50%.
• QTcF interval >470 ms.
• Any of the following within the past 6 months prior to enrollment: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic events.
• Clinically severe pulmonary compromise (ie, requiring any supplemental oxygen) resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.

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

Япония · 2 центра

• National Cancer Center Hospital — Chūōku
• National Cancer Center Hospital East — Kashiwa

Идентификаторы

NCT: NCT07159126 · DS3610-071 · 2025-521173-13-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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