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

NCT ID: NCT06073938

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2025-06-30

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.

Conditions

Advanced Solid Tumors or Lymphomas

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Province Tumor Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongchang Zhang

Professor, Deputy Director of Thoracic Oncology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hunan Provincal Tumor Hospital

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongchang Zhang, MD

Role: CONTACT

zhangyongchang@csu.edu.cn

+8613873123436 ext. 7+861383123436

Nong Yang

Role: CONTACT

yangnong0217@163.com

+8613873123436

Facility Contacts

Nong Yang, MD

Role: primary

yangnong0217@163.com

+86 731 89762323

Yongchang Zhang, MD

Role: backup

zhangyongchang@csu.edu.cn

+86 731 89762327

Other Identifiers

BRD-870 RWS

Identifier Type: -

Identifier Source: org_study_id