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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Advanced Solid Tumors or Lymphomas

Intervention / Treatment
-----------------
* Drug: NHWD-870


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Proportion of patients whose tumor volume shrinks to a pre-specified value (usually 30%) and who are able to maintain the minimum timeframe requirements. | 1.5 years |