NCT06781567RecruitingPhase 2
Clinical Trial of HG146 Administered to Participants With Adenoid Cystic Carcinoma
A Phase Il Clinical Study to Evaluate the Efficacy and Safety of HG146 Capsules in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma.
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 6 Jan 2025
- Start date
- 13 Dec 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- HitGen Inc.
- Diseases
- Head and neck cancer
- NCT number
- NCT06781567
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 140
- From 13 Dec 2024 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- A person is known to be allergic to any active ingredient or excipient of the investigational drug.
- patients with drug abuse or chronic alcohol abuse that may affect the evaluation of the test results.
Other illness
- 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.
Other
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Oriental Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.