Adenoid Cystic CarcinomaPhase 2HG146NCT06781567
Clinical Trial of HG146 Administered to Participants With Adenoid Cystic Carcinoma
A Phase 2 study testing HG146 in people with Adenoid Cystic Carcinoma and Head and Neck Cancer, run by HitGen Inc. at 1 site in China.
Trial summary
This is a Phase II, open-label, non-randomized, multicenter study to evaluate the clinical efficacy and safety of HG146 in participants with recurrent or metastatic adenoid cystic carcinoma. This study is divided into two stages. 40 participants will be enrolled in the first stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoid Cystic Carcinoma, Head and Neck Cancer
- What is being tested?
- HG146
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2024to 30 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form (ICF) and able to comply with study.
- Age ≥18 years, gender unlimited.
- Recurrent or metastatic adenoid cystic carcinoma with evidence of disease progression (imaging progression or clinical evidence of progression) within one year of histological or cytological diagnosis.
- Estimated survival >12 weeks, as determined by the investigator.
- The United States Eastern Cancer Consortium (ECOG) physical status score 0-1.
- Has adequate organ function.
- At least 1 measurable tumor lesion according to RECISTv1.1 criteria.
Who cannot join
- Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment.
- Received prior therapies targeting HDAC.
- Chemotherapy was received within 21 days before the first administration of the study treatment, and anti-tumor therapy such as radiotherapy, biotherapy, targeted therapy, and immunotherapy was received within 28 days before the first administration of the study treatment [small molecule targeted drugs, Chinese medicines with anti-tumor indications, and local palliative radiotherapy were 14 times before the first administration of the study drug.
- Used strong CYP3A4 inhibitors or inducers within 7 days before the first use of the investigational drug.
- Major surgery or major injury <=28 days before the first dose of study treatment,or anticipated major surgery during the study.
- Prior allogeneic bone marrow transplantation or other solid organ transplantation
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- Active infection requiring systemic treatment.
- Current or past presence of other malignancies (other than adequately treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix), unless radical treatment has been performed and there is no evidence of recurrence and metastasis in the last 5 years.
- A person is known to be allergic to any active ingredient or excipient of the investigational drug.
- Pregnant or lactating women.
- patients with drug abuse or chronic alcohol abuse that may affect the evaluation of the test results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, 200000
Ye Guo, 8268-85197385, pattrickguo@gmail.com
About this study
Official title: A Phase Il Clinical Study to Evaluate the Efficacy and Safety of HG146 Capsules in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma.
This is a Phase II, open-label, non-randomized, multicenter study to evaluate the clinical efficacy and safety of HG146 in participants with recurrent or metastatic adenoid cystic carcinoma. This study is divided into two stages. 40 participants will be enrolled in the first stage. The efficacy and safty data will apply to make go or no go decision. Then the second stage will continue to enroll 100 Particapants.
- Conditions
- Adenoid Cystic Carcinoma, Head and Neck Cancer
- Being tested
- HG146
- Keywords
- HG146, HG146CN201
- Medical subject headings
- Carcinoma, Adenoid Cystic, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HG146Drug
Also called HG146 Capsule
HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Trial of HG146 Administered to participants with Adenoid cystic carcinoma | Experimental | Experimental: HG146 Monotherapy Arm Description: Participants will receive HG146 per os at every two days intervals (qod) for 14 consecutive days,7 days off, 21 days/ cycle. Receives: Drug: HG146 |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
ORR will be assessed by the investigators using RECIST v1.1
Measured: From enrollment to the end of treatment at 4 weeks
6 Months Progression-Free Survival （PFS）
PFS will be assessed by the investigators using RECIST v. 1.1
Measured: From enrollment to treatment at 6 months.
Secondary outcomes (6)
Progression-Free Survival （PFS）
PFS will be assessed by the investigators using RECIST v1.1
Measured: From enrollment to treatment at 12 months
Duration of response (DoR)
DOR will be assessed by the investigators using RECIST v1.1
Measured: From enrollment to the end of treatment at 4 weeks
Disease control rate (DCR)
DCR will be assessed by the investigators using RECIST v1.1
Measured: From enrollment to the end of treatment at 4 weeks
Overall survival (OS)
OS will be assessed by the investigators
Measured: From enrollment to the end of treatment at 4 weeks
Time-to-response (TTR)
TTR will be assessed by the investigators using RECIST v1.1
Measured: From enrollment to the end of treatment at 4 weeks
Population pharmacokinetics (PopPK)
PopPK will be detected to predict exposure level of HG146 in human body.
Measured: From Cycle1 Day7 to Day13, 21 days per cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start13 Dec 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid Cystic CarcinomaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HitGen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ye Guo, Principal investigator, Shanghai Oriental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781567
- Sponsor's protocol ID
- HG146CN201
- Acronym
- HG146
- Status last verified
- Sep 2026
- First submitted
- 6 Jan 2025
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Il Clinical Study to Evaluate the Efficacy and Safety of HG146 Capsules in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma.
- ClinicalTrials.gov ID
- NCT06781567
- Acronym / sponsor ID
- HG146 / HG146CN201
- Conditions
- Adenoid Cystic Carcinoma, Head and Neck Cancer
- Keywords
- HG146, HG146CN201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- HitGen Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Jan 2025 (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 Phase II, open-label, non-randomized, multicenter study to evaluate the clinical efficacy and safety of HG146 in participants with recurrent or metastatic adenoid cystic carcinoma. This study is divided into two stages. 40 participants will be enrolled in the first stage. The efficacy and safty data will apply to make go or no go decision. Then the second stage will continue to enroll 100 Particapants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Trial of HG146 Administered to participants with Adenoid cystic carcinoma | Experimental | Drug: HG146Experimental: HG146 Monotherapy Arm Description: Participants will receive HG146 per os at every two days intervals (qod) for 14 consecutive days,7 days off, 21 days/ cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent form (ICF) and able to comply with study.
- Age ≥18 years, gender unlimited.
- Recurrent or metastatic adenoid cystic carcinoma with evidence of disease progression (imaging progression or clinical evidence of progression) within one year of histological or cytological diagnosis.
- Estimated survival >12 weeks, as determined by the investigator.
- The United States Eastern Cancer Consortium (ECOG) physical status score 0-1.
Key exclusion criteria (11 listed)
- Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment.
- Received prior therapies targeting HDAC.
- Chemotherapy was received within 21 days before the first administration of the study treatment, and anti-tumor therapy such as radiotherapy, biotherapy, targeted therapy, and immunotherapy was received within 28 days before the first administration of the study treatment [small molecule targeted drugs, Chinese medicines with anti-tumor indications, and local palliative radiotherapy were 14 times before the first administration of the study drug.
- Used strong CYP3A4 inhibitors or inducers within 7 days before the first use of the investigational drug.
- Major surgery or major injury <=28 days before the first dose of study treatment,or anticipated major surgery during the 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 |
|---|---|---|
| HG146Also: HG146 CapsuleHG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg. | Drug | Clinical Trial of HG146 Administered to participants with Adenoid cystic carcinoma |
Primary outcome
objective response rate (ORR)
Time frame: From enrollment to the end of treatment at 4 weeks
ORR will be assessed by the investigators using RECIST v1.1
6 Months Progression-Free Survival （PFS）
Time frame: From enrollment to treatment at 6 months.
PFS will be assessed by the investigators using RECIST v. 1.1
6 secondary outcomes
Progression-Free Survival （PFS）
Time frame: From enrollment to treatment at 12 months
Duration of response (DoR)
Time frame: From enrollment to the end of treatment at 4 weeks
Disease control rate (DCR)
Time frame: From enrollment to the end of treatment at 4 weeks
Overall survival (OS)
Time frame: From enrollment to the end of treatment at 4 weeks
Time-to-response (TTR)
Time frame: From enrollment to the end of treatment at 4 weeks
Population pharmacokinetics (PopPK)
Time frame: From Cycle1 Day7 to Day13, 21 days per cycle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- 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.
Ye Guo principal investigator
Shanghai Oriental Hospital
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 HG146 in people with Adenoid Cystic Carcinoma and Head and Neck Cancer, run by HitGen Inc. 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Shen (8268-85197385 ext. 8211, jie.shen@hitgen.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: From enrollment to the end of treatment at 4 weeks). The study lists 2 primary outcomes in all. 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 21 Sep 2026.