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

ConditionAdvanced Solid Tumor (Phase 1)
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • NHWD-870 HCl

    Drug

    Administered P.O.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Adult：NHWD-870 HCl 2mg ； Adolescent：NHWD-870 HCl 1.5mg/2mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Time frame
Completed at least four weeks of treatment, the curative effect evaluation of CR, PR and maintain at least 4 weeks, the proportion of the subjects,up to 5 months;

Secondary outcomes

1

Duration of response (DoR)

Time frame
Completed at least four weeks of treatment,first time participants from CR or PR to onset of disease (PD),up to 5 months;
2

Disease control rate (DCR)

Time frame
Completed at least four weeks of treatment,tumor curative effect evaluation of CR, PR and SD proportion of subjects,up to 5 months;
3

Progression-free survival (PFS)

Time frame
From start studying drug therapy to the disease progression or any reason for the first time the time of death,up to 12 months;
4

time to remission (TTR)

Time frame
From the beginning the study drug therapy to ease for the first time (including patients with CR and PR),up to 5 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Wenda Pharma Technology LTD.

Lead sponsor

Source ClinicalTrials.gov
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