Advanced Solid Tumor (Phase 1)Phase 2NCT06527300
A Multicenter, Open-label, Single-arm, Phase II Study of NHWD-870 HCl in Adults and Adolescents with Advanced NUT Cancer
A Phase 2 study testing NHWD-870 HCl in people with Advanced Solid Tumor (Phase 1), run by Zhejiang Wenda Pharma Technology LTD. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Advanced Solid Tumor (Phase 1)
- What is being tested?
- NHWD-870 HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2024to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Three Gorges Hospital Affiliated to Chongqing University
Chongqing, 404100
Chao Deng, Doctor, +86 023-58103064, cqsxyyll@163.com
About this study
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)
- Being tested
- NHWD-870 HCl
- Keywords
- NHWD-870
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHWD-870 HClDrug
Administered P.O.
| Study group | Role | What they receive |
|---|---|---|
| Adult：NHWD-870 HCl 2mg ； Adolescent：NHWD-870 HCl 1.5mg/2mg | Experimental | Take a fixed dose of NHWD-870 HCl tablets orally. Receives: Drug: NHWD-870 HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: 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 (4)
Duration of response (DoR)
Measured: Completed at least four weeks of treatment,first time participants from CR or PR to onset of disease (PD),up to 5 months;
Disease control rate (DCR)
Measured: Completed at least four weeks of treatment,tumor curative effect evaluation of CR, PR and SD proportion of subjects,up to 5 months;
Progression-free survival (PFS)
Measured: From start studying drug therapy to the disease progression or any reason for the first time the time of death,up to 12 months;
time to remission (TTR)
Measured: From the beginning the study drug therapy to ease for the first time (including patients with CR and PR),up to 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start25 Apr 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor (Phase 1)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Wenda Pharma Technology LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527300
- Sponsor's protocol ID
- NHWD-870 HCl-II-02
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single-arm, Phase II Study of NHWD-870 HCl in Adults and Adolescents with Advanced NUT Cancer
- ClinicalTrials.gov ID
- NCT06527300
- Acronym / sponsor ID
- NHWD-870 HCl-II-02
- Conditions
- Advanced Solid Tumor (Phase 1)
- Keywords
- NHWD-870
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Zhejiang Wenda Pharma Technology LTD.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult：NHWD-870 HCl 2mg ； Adolescent：NHWD-870 HCl 1.5mg/2mg | Experimental | Drug: NHWD-870 HClTake a fixed dose of NHWD-870 HCl tablets orally. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NHWD-870 HClAdministered P.O. | Drug | Adult：NHWD-870 HCl 2mg ； Adolescent：NHWD-870 HCl 1.5mg/2mg |
Primary outcome
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;
4 secondary outcomes
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;
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;
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;
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NHWD-870 HCl in people with Advanced Solid Tumor (Phase 1), run by Zhejiang Wenda Pharma Technology LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao Deng, Doctor (+86 023-58103064, cqsxyyll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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;). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.