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Trial Title:
Compassionate Use Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement
NCT ID:
NCT06073938
Condition:
Advanced Solid Tumors or Lymphomas
Conditions: Official terms:
Lymphoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
NHWD-870
Description:
The base dosage administered is 2.0 mg/dose/day, and the frequency and dose of
administration may be adjusted based on safety data.
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.
Criteria for eligibility:
Study pop:
advanced solid tumors or lymphomas, NUT rearrangement positive
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Provincal Tumor Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Nong Yang, MD
Phone:
+86 731 89762323
Email:
yangnong0217@163.com
Contact backup:
Last name:
Yongchang Zhang, MD
Phone:
+86 731 89762327
Email:
zhangyongchang@csu.edu.cn
Investigator:
Last name:
Nong Yang, MD
Email:
Principal Investigator
Start date:
September 20, 2022
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Hunan Province Tumor Hospital
Agency class:
Other
Source:
Hunan Province Tumor Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073938
