DBC-664 in Adult Patients With Solid Tumors

Официальное название

A Phase 1a/1b Open Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of DBC-664 in Adult Patients With Locally Advanced or Metastatic Solid Tumors

Обзор

DBC-664-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamic, and preliminary anti-tumor activity of DBC-664 in patients with endometrial cancer, ovarian cancer, and other advanced solid tumors . This study is divided into 2 parts: Phase-1a Dose Escalation (Part 1), and Phase-1b Dose Expansion (Part 2). In each part, patients who meet specific eligibility criteria will be enrolled.

Вмешательства

• Биопрепарат DBC-664
  DBC-664 will be administered intravenously.

Первичные конечные точки

• Safety and Tolerability [Срок оценки: 2 years]
• Determine Recommended Dose for Expansion [Срок оценки: 1 year]
• Characterize Pharmacokinetics [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Must be ≥18 years of age at the time consent is signed.
• Has a histologically or cytologically confirmed unresectable recurrent locally advanced or metastatic solid tumor
• Has measurable disease per RECIST v1.1 (or mRECIST 1.1 for patients with pleural mesothelioma), as assessed by the local site Investigator/radiology.

Критерии исключения

• Has a diagnosis of immunodeficiency.
• Has had a prior stem cell, bone marrow, or organ transplant.
• Has a known history of human immunodeficiency virus (HIV) infection.
• Has active or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
• Has an active autoimmune disease (non-immunotherapy induced conditions) that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
• Has a history of (noninfectious) pneumonitis that required steroids or current active pneumonitis/interstitial lung disease.
• Has symptomatic visceral spread of disease that poses a risk of life-threatening complications in the short term, per Investigator's opinion (including massive uncontrolled effusions \[pleural, pericardial, peritoneal\], pulmonary lymphangitis, and over 50% liver involvement).
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated CNS metastases may participate provided they are radiologically stable (ie, without evidence of progression for at least 2 weeks by repeat imaging \[note that the repeat imaging should be performed during study Screening\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
• Has a history of a previous secondary malignancy within 3 years of Screening (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative therapy or other localized, low-grade tumors deemed cured, or whose natural history does not have the potential to interfere with the safety or efficacy assessments of the current study and not treated with systemic anticancer therapy \[except hormonal therapy\]).
• Has a known psychiatric or substance abuse disorder that would interfere with the individuals' ability to cooperate with the requirements of the study.

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 · 3 центра

• START Midwest — Grand Rapids
• START New Jersey — East Brunswick
• START New York — Lake Success

Идентификаторы

NCT: NCT07705035 · DBC-664-ONC-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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