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

NCT ID: NCT06527300

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-25
• Study Completion Date: 2025-12-30

Brief 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.

Conditions

Advanced Solid Tumor (Phase 1)

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adult：NHWD-870 HCl 2mg ； Adolescent：NHWD-870 HCl 1.5mg/2mg

Take a fixed dose of NHWD-870 HCl tablets orally.

Group Type: EXPERIMENTAL

NHWD-870 HCl

Intervention Type: DRUG

Administered P.O.

Interventions

NHWD-870 HCl

Administered P.O.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Wenda Pharma Technology LTD.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Three Gorges Hospital Affiliated to Chongqing University

Chongqing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chao Deng, Doctor

Role: CONTACT

cqsxyyll@163.com

+86 023-58103064

Facility Contacts

Chao Deng, Doctor

Role: primary

cqsxyyll@163.com

+86 023-58103064

Other Identifiers

NHWD-870 HCl-II-02

Identifier Type: -

Identifier Source: org_study_id