A Multicenter, Open-label, Single-arm, Phase II Study of NHWD-870 HCl in Adults and Adolescents with Advanced NUT Cancer

Last updated: January 21, 2025
Sponsor: Zhejiang Wenda Medical Technology Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

NHWD-870 HCl

Clinical Study ID

NCT06527300
NHWD-870 HCl-II-02
  • Ages 12-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A written informed consent signed;

  • Subjects must sign and date IEC-approved written informed consent in accordance withthe guidelines of the competent authorities and research institutions. Informedconsent had to be obtained before any protocol-related procedure that was not partof a participant's routine care was performed.

  • Participants must be willing and able to comply with the scheduled visits, treatmentprotocols, laboratory tests, and other requirements of the study;

  • If the subjects were under 18, the participants and their legal guardianauthorization signed agreement;

  • Both sexes, the first part (adult group) was ≥18 years old and ≤75 years old, thesecond 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 tothe tumor tissue pathologic specimens before three years, if more than 3 yearsshould be confirmed in the center of the study to do a biopsy. If, in theinvestigator's judgment, a biopsy might increase a subject's risk, archival tumortissue samples up to 3 years old could be collected after discussion with thesponsor) 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-foldamplification) by DNA/RNA sequencing.

Exclusion

Exclusion Criteria:

  • Prior treatment with a BET inhibitor;

  • 3 years before into the group suffering from other malignant tumors, with theexception of removal of cure of basal cell carcinoma, orthotopic bladder cancer orcervical carcinoma in situ;

  • The researchers believe the subjects is the need for systemic anti-infectiontreatment of active infection;

  • Patients with clinically significant bleeding symptoms or clear bleeding tendencywithin 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagicgastric ulcer, etc.

  • Imaging shows that the tumor has invaded important blood vessels or theinvestigators judge that the tumor is likely to invade important blood vessels andcause fatal hemorrhage during the follow-up study.

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: NHWD-870 HCl
Phase: 2
Study Start date:
April 25, 2024
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Three Gorges Hospital Affiliated to Chongqing University

    Chongqing, 404100
    China

    Active - Recruiting

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