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Recruiting NCT06073938

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

— Observational Advanced Solid Tumors or Lymphomas

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NHWD-870.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors or Lymphomas. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • ORR [Time frame: 1.5 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Hunan Provincal Tumor Hospital — Changsha

Publications

  • 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

Identifiers

NCT: NCT06073938 · BRD-870 RWS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗