Actively Recruiting
Compassionate Use Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement
Led by Hunan Province Tumor Hospital · Updated on 2024-09-19
30
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Compassionate Use Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Diagnosed with advanced solid tumors or lymphomas confirmed by pathology
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 1
- Expected survival longer than 3 months
- NUT positive confirmed by molecular testing
You will not qualify if you...
- Serious complications like uncontrolled infection, recent myocardial infarction (within 6 months), high blood pressure (≥160/100 mmHg), or thromboembolic disease not controlled by drugs
- Unresolved adverse reactions from prior anti-tumor therapy above CTCAE 5.0 Grade 1 (except hair loss, anemia, or other toxicities deemed safe by researchers)
- History of substance abuse
- Difficulty swallowing drugs (unless receiving nutrients via gastric tube) or conditions severely affecting gastrointestinal absorption
- History of serious systemic diseases making participation unsuitable as judged by investigator
- Alcoholic or consuming more than 28 units of alcohol per week
- Uncontrollable mental illness
- Pregnant or breastfeeding women, or patients of childbearing age with plans for pregnancy
- Active hepatitis B (viral titer >10^3), hepatitis C, or HIV infection
- Long-term high-dose corticosteroids or immunosuppressants use, including recent systemic glucocorticoid or immunosuppressant therapy within 14 days prior to first study drug dose (exceptions for certain topical or short-term uses)
- Investigator's judgment that participation is unsuitable for other objective reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hunan Provincal Tumor Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
Y
Yongchang Zhang, MD
CONTACT
N
Nong Yang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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