Use of NHWD-870 for patients with advanced tumors or lymphomas with NUT rearrangement

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

This study is testing a new treatment called NHWD-870 to see if it can help people with advanced tumors or lymphomas that have a specific genetic change.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hunan Province Tumor Hospital (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT06073938 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the safety and preliminary efficacy of NHWD-870 in patients diagnosed with advanced solid tumors or lymphomas that carry NUT rearrangement. It aims to assess the pharmacokinetics and pharmacodynamics of the treatment while identifying biomarkers that may predict its effectiveness. The study will help establish a foundation for selecting patients for future late-stage trials based on their response to NHWD-870.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced solid tumors or lymphomas confirmed by pathology and carrying NUT rearrangement.

Not a fit: Patients with serious complications or those who have not recovered from previous anti-tumor therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced tumors or lymphomas that are currently difficult to treat.

How similar studies have performed: While this approach is focused on a specific genetic rearrangement, similar studies have shown promise in targeting specific biomarkers in advanced cancers.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

1. 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.);
2. 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);
3. History of substance abuse;
4. 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;
5. Patients with a history of other serious systemic diseases who are judged by the investigator to be unsuitable for participating in clinical trials;
6. 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);
7. Suffering from uncontrollable mental illness;
8. Pregnant or lactating women, or patients of childbearing age (including male subjects) with pregnancy plans;
9. Active hepatitis B (viral titer \>103), hepatitis C or HIV ( );
10. 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);
11. The investigator believes that the subject is not suitable to participate in this clinical study for other objective reasons.

Where this trial is running

Changsha, Hunan

• Hunan Provincal Tumor Hospital — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Yongchang Zhang, MD

Conditions Advanced Solid Tumors or Lymphomas