Advanced Solid Tumors or Lymphomas
Conditions
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.
Interventions
DRUGNHWD-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.
Sponsors
Hunan Province Tumor Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 1.5 years | Proportion of patients whose tumor volume shrinks to a pre-specified value (usually 30%) and who are able to maintain the minimum timeframe requirements. |
Countries
China
Contacts
Primary ContactYongchang Zhang, MD
Backup ContactNong Yang
Outcome results
None listed