Compassionate Use Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement

Официальное название

A Real-World Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement

Обзор

The NHWD-870 Phase I clinical trial evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with advanced tumors. The objectives of this retrospective study were to preliminarily evaluate the anti-tumor efficacy of NHWD-870 HCl in patients with advanced solid tumors or lymphomas and to preliminarily evaluate biomarkers associated with the efficacy of NHWD-870 HCl in the treatment of patients with advanced solid tumors or lymphomas, to provide a basis for identifying the enriched population for the late-stage trial.

Вмешательства

• Препарат NHWD-870
  The base dosage administered is 2.0 mg/dose/day, and the frequency and dose of administration may be adjusted based on safety data.

Первичные конечные точки

• ORR [Срок оценки: 1.5 years]

Критерии участия

Критерии включения

• Signing an informed consent form;
• Patients with advanced solid tumors or lymphomas definitively diagnosed by pathology;
• Age ≥18 and ≤75 years;
• Eastern Cooperative Oncology Group (ECOG) score physical status score of 0 to 1;
• Expected survival of >3 months;
• NUT positive confirmed by molecular testing.

Критерии исключения

Subjects who meet one or more of the following criteria will be excluded:

• Other serious complications (such as uncontrolled infection, myocardial infarction within 6 months, high blood pressure (≥ 160/100mmHg) and thromboembolic disease that cannot be controlled by drug intervention, etc.);
• The adverse reactions of previous anti-tumor therapy have not been restored to CTCAE 5.0 ≤ Grade1 (except for hair loss, anemia and other toxicities judged by researchers to be unsafe);
• History of substance abuse;
• Inability to take drugs due to dysphagia (except for patients who receive nutrients through a gastric tube due to dysphagia), or conditions that the investigator determines seriously affect gastrointestinal absorption;
• Patients with a history of other serious systemic diseases who are judged by the investigator to be unsuitable for participating in clinical trials;
• Alcoholics or those who drink more than 28 units of alcohol per week (1 unit = 285 mL of beer or 25 mL of spirits or 1 glass of wine);
• Suffering from uncontrollable mental illness;
• Pregnant or lactating women, or patients of childbearing age (including male subjects) with pregnancy plans;
• Active hepatitis B (viral titer >103), hepatitis C or HIV ( );
• Long-term treatment with high-dose corticosteroids or other immunosuppressants, such as those who have undergone organ transplantation, or those who have received systemic glucocorticoids (such as prednisone> 10 mg/day or equivalent drugs) or other immunosuppressant therapy within 14 days before the first use of the study drug; Exceptions are given for topical, ocular, intra-articular, intranasal and inhaled corticosteroid therapy; short-term use of glucocorticoids for prophylaxis (e.g., prevention of contrast allergy);
• The investigator believes that the subject is not suitable to participate in this clinical study for other objective reasons.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Hunan Provincal Tumor Hospital — Чанша

Публикации

• Ye Z, Yan H, Li X, Yang D, Xie F, Deng C, Yin M. Radiotherapy Outcomes and Prognostic Factors in Head and Neck NUT Carcinoma: A Single-Center Cohort Analysis. Head Neck. 2026 Apr;48(4):975-985. doi: 10.1002/hed.70119. Epub 2025 Dec 2. PMID 41328494

Идентификаторы

NCT: NCT06073938 · BRD-870 RWS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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