Evaluating HG146 for patients with adenoid cystic carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical trial is designed to assess the safety and efficacy of HG146 in patients suffering from recurrent or metastatic adenoid cystic carcinoma. The study will enroll participants in two stages, starting with 40 individuals to gather initial efficacy and safety data, followed by an additional 100 participants based on the results of the first stage. The trial is open-label and non-randomized, allowing for a direct evaluation of the treatment's impact on the disease. Participants will be monitored for disease progression and overall health throughout the study.

Why it matters

Who can join: the full rules

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:

* 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.

Where it's running

• Shanghai Oriental Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Ye Guo — Shanghai Oriental Hospital
• Study coordinator: Jie Shen
• Email: jie.shen@hitgen.com
• Phone: 8268-85197385

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.