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RecruitingNCT06781567HG146Updated Sep 21, 2026

Clinical Trial of HG146 Administered to Participants With Adenoid Cystic Carcinoma

A Phase 2 interventional study of HG146 in Adenoid Cystic Carcinoma and Head and Neck Cancer, sponsored by HitGen Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by HitGen Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. The efficacy and safty data will apply to make go or no go decision. Then the second stage will continue to enroll 100 Particapants.

02

Conditions studied

  • Adenoid Cystic Carcinoma
  • Head and Neck Cancer

Keywords

  • HG146
  • HG146CN201
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Clinical Trial of HG146 Administered to participants with Adenoid cystic carcinoma

    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.

    Drug: HG146

Interventions

  • DrugHG146

    HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.

    Also known as: HG146 Capsule

05

What researchers measure

Primary outcomes

  1. objective response rate (ORR)

    ORR will be assessed by the investigators using RECIST v1.1

    Time frame: From enrollment to the end of treatment at 4 weeks

  2. 6 Months Progression-Free Survival (PFS)

    PFS will be assessed by the investigators using RECIST v. 1.1

    Time frame: From enrollment to treatment at 6 months.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    PFS will be assessed by the investigators using RECIST v1.1

    Time frame: From enrollment to treatment at 12 months

  2. Duration of response (DoR)

    DOR will be assessed by the investigators using RECIST v1.1

    Time frame: From enrollment to the end of treatment at 4 weeks

  3. Disease control rate (DCR)

    DCR will be assessed by the investigators using RECIST v1.1

    Time frame: From enrollment to the end of treatment at 4 weeks

  4. Overall survival (OS)

    OS will be assessed by the investigators

    Time frame: From enrollment to the end of treatment at 4 weeks

  5. Time-to-response (TTR)

    TTR will be assessed by the investigators using RECIST v1.1

    Time frame: From enrollment to the end of treatment at 4 weeks

  6. Population pharmacokinetics (PopPK)

    PopPK will be detected to predict exposure level of HG146 in human body.

    Time frame: From Cycle1 Day7 to Day13, 21 days per cycle

06

Study locations

1 of 1 sites recruiting
  • Shanghai Oriental Hospital
    Shanghai, Shanghai Municipality 200000, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06781567
Lead sponsor
HitGen Inc.
Responsible party
Sponsor
First posted
Jan 17, 2025
Start date
Dec 13, 2024
Primary completion
Dec 31, 2028 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Sep 21, 2026

Study contacts

Jie Shen
Contact
jie.shen@hitgen.com
8268-85197385 ext. 8211
Ye Guo
principal investigator · Shanghai Oriental Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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