Evaluating NHWD-870 HCl for Advanced NUT Cancer

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

This study is testing a new drug called NHWD-870 HCl to see if it helps adults and teenagers with advanced NUT cancer feel better and stay safe while using it.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 12 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang Wenda Pharma Technology LTD. (Academic / other)
• Locations: 1 site (Chongqing)
• Trial ID: NCT06527300 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, single-arm phase II study aims to assess the efficacy, safety, and pharmacokinetics of NHWD-870 HCl in adults and adolescents diagnosed with advanced NUT cancer. Participants will receive the treatment and be monitored for their response and any side effects. The study will include both adult and adolescent populations, ensuring a comprehensive evaluation of the drug's effects across different age groups.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 and adolescents aged 12-17 with a confirmed diagnosis of advanced NUT cancer.

Not a fit: Patients with early-stage NUT cancer or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from advanced NUT cancer.

How similar studies have performed: While there may be limited data on NHWD-870 specifically, similar studies targeting advanced solid tumors have shown promise in developing new treatment options.

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.

Where this trial is running

Chongqing

• Three Gorges Hospital Affiliated to Chongqing University — Chongqing, China (Recruiting)

Study contacts

• Study coordinator: Chao Deng, Doctor

Conditions Advanced Solid Tumor; NHWD-870