Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06073938

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NHWD-870

Drug

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 outcomes

  1. ORR

    Time frame: 1.5 years

    Proportion of patients whose tumor volume shrinks to a pre-specified value (usually 30%) and who are able to maintain the minimum timeframe requirements.

Study contacts

Contact information is provided by the study sponsor or research team.

Nong Yang

CONTACT

[email protected]

+8613873123436

Yongchang Zhang, MD

CONTACT

[email protected]

+8613873123436 ext. 7+861383123436

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Oct 10, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.