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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-75
SponsorZhejiang Wenda Pharma Technology LTD.

About this trial

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

Qualifiers

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;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • NHWD-870 HCl

Treatment groups

48 Participants
are divided into 1 treatment group