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Trial Title:
A Multicenter, Open-label, Single-arm, Phase II Study of NHWD-870 HCl in Adults and Adolescents With Advanced NUT Cancer
NCT ID:
NCT06527300
Condition:
Patients With Advanced NUT Cancer
Conditions: Keywords:
NHWD-870
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
NHWD-870 HCl
Description:
Administered P.O.
Arm group label:
NHWD-870 HCl 1.5mg/2mg.
Summary:
This is a multicenter, open-label, single-arm, phase II study to evaluate the efficacy,
safety, and pharmacokinetics of NHWD-870 HCl in adults and adolescents with advanced NUT
cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- A written informed consent signed;
- Subjects must sign and date IEC-approved written informed consent in accordance with
the guidelines of the competent authorities and research institutions. Informed
consent had to be obtained before any protocol-related procedure that was not part
of a participant's routine care was performed.
- Participants must be willing and able to comply with the scheduled visits, treatment
protocols, laboratory tests, and other requirements of the study;
- If the subjects were under 18, the participants and their legal guardian
authorization signed agreement;
- Both sexes, the first part (adult group) was ≥18 years old and ≤75 years old, the
second part (adolescent group) was ≥12 years old and <18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- The expected survival period for 3 months or more;
- The histopathological (histopathological diagnosis was the first time according to
the tumor tissue pathologic specimens before three years, if more than 3 years
should be confirmed in the center of the study to do a biopsy. If, in the
investigator's judgment, a biopsy might increase a subject's risk, archival tumor
tissue samples up to 3 years old could be collected after discussion with the
sponsor) were diagnosed as midline (NUT) cancer by, but not limited to:
- Determination of ectopic NUT protein expression by IHC;
- Detection of NUT gene translocations by fluorescence in situ hybridization (FISH);
- Detection of NUT gene translocations (e.g. BRD3/4 mutation or ≥ 2-fold
amplification) by DNA/RNA sequencing.
Exclusion Criteria:
- Prior treatment with a BET inhibitor;
- 3 years before into the group suffering from other malignant tumors, with the
exception of removal of cure of basal cell carcinoma, orthotopic bladder cancer or
cervical carcinoma in situ;
- The researchers believe the subjects is the need for systemic anti-infection
treatment of active infection;
- Patients with clinically significant bleeding symptoms or clear bleeding tendency
within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic
gastric ulcer, etc.
- Imaging shows that the tumor has invaded important blood vessels or the
investigators judge that the tumor is likely to invade important blood vessels and
cause fatal hemorrhage during the follow-up study.
Gender:
All
Minimum age:
12 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Three Gorges Hospital Affiliated to Chongqing University
Address:
City:
Chongqing
Zip:
404100
Country:
China
Status:
Recruiting
Contact:
Last name:
Chao Deng, Doctor
Phone:
+86 023-58103064
Email:
cqsxyyll@163.com
Start date:
April 25, 2024
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Zhejiang Wenda Medical Technology Co., Ltd.
Agency class:
Other
Source:
Zhejiang Wenda Medical Technology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06527300
