Status:
RECRUITING
Compassionate Use Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement
Lead Sponsor:
Hunan Province Tumor Hospital
Conditions:
Advanced Solid Tumors or Lymphomas
Eligibility:
All Genders
18-75 years
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 preli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06073938
Start Date
September 20 2022
End Date
June 30 2025
Last Update
September 19 2024
Active Locations (1)
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1
Hunan Provincal Tumor Hospital
Changsha, Hunan, China, 410013