Clinical trial NCT06073938: Compassionate Use Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement
Official title: A Real-World Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Solid Tumors or Lymphomas
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: advanced solid tumors or lymphomas, NUT rearrangement positive

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.


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.

Primary outcomes:
measure: ORR
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincal Tumor Hospital
state: Hunan
Study officials:
References: