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

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 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.