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

Advanced Solid Tumors or Lymphomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073938
• Other study ID #: BRD-870 RWS
• Status: Recruiting
• Start date: September 20, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Hunan Province Tumor Hospital
• Contact: Yongchang Zhang, MD
• Phone: +8613873123436
• Email: zhangyongchang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors or Lymphomas
• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
China	Hunan Provincal Tumor Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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