Actively Recruiting
A Multicenter, Open-label, Single-arm, Phase II Study of NHWD-870 HCl in Adults and Adolescents with Advanced NUT Cancer
Led by Zhejiang Wenda Pharma Technology LTD. · Updated on 2025-01-24
48
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug NHWD-870 HCl in adults and adolescents with advanced NUT cancer, a rare and aggressive solid tumor. This multicenter, open-label, single-arm phase II study aims to assess how well the drug works, its safety, and how the body processes it in this patient group. The study is sponsored by Zhejiang Wenda Pharma Technology LTD. and focuses on participants aged 12 to 75 years. Participants will take a fixed oral dose of NHWD-870 HCl tablets, with adults receiving 2 mg and adolescents receiving 1.5 mg or 2 mg. This treatment is given continuously, and there is no placebo or comparison group. The study includes an initial treatment period lasting up to several months, during which researchers closely monitor the participants' response to the drug and any side effects. During the study, participants will have scheduled visits for treatment, laboratory tests, and tumor evaluations. Researchers will measure outcomes such as objective response rate, duration of response, disease control rate, progression-free survival, and time to remission over periods ranging from 5 to 12 months. The study also tracks safety and tolerability throughout. Total participation lasts until the end of treatment and follow-up assessments, with the study concluding by the end of 2025.
CONDITIONS
Brief Title
A Multicenter, Open-label, Single-arm, Phase II Study of NHWD-870 HCl in Adults and Adolescents with Advanced NUT Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent according to guidelines before any study procedures
- Willing and able to comply with study visits, treatment, and tests
- Signed agreement from legal guardian if under 18
- Both sexes eligible; adults aged 18 to 75 years, adolescents aged 12 to under 18 years
- ECOG performance status score between 0 and 2
- Expected survival of at least 3 months
- Histopathological diagnosis of midline (NUT) cancer within the past 3 years confirmed by IHC, FISH, or DNA/RNA sequencing
You will not qualify if you...
- Prior treatment with a BET inhibitor
- Other malignant tumors within the past 3 years except cured basal cell carcinoma, bladder cancer, or cervical carcinoma in situ
- Active infection requiring systemic anti-infection treatment
- Significant bleeding symptoms or bleeding tendency within 3 months before enrollment
- Tumor invasion of important blood vessels or risk of fatal hemorrhage as judged by imaging or investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 months
Participants take a fixed dose of NHWD-870 HCl tablets orally to treat advanced NUT cancer.
Visits as scheduled during treatment
Duration - Up to 7 months following treatment completion
Participants are monitored for disease progression or survival outcomes after treatment ends.
Visits as scheduled up to 12 months from treatment start
Trial Site Locations
Total: 1 location
1
Three Gorges Hospital Affiliated to Chongqing University
Chongqing, China, 404100
Actively Recruiting
Research Team
C
Chao Deng, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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