Evaluating HG146 for patients 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.
This study is testing a new treatment called HG146 to see if it can help people with recurrent or metastatic adenoid cystic carcinoma feel better and manage their disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HitGen Inc. Industry-sponsored |
| Drugs / interventions | Chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06781567 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with recurrent or metastatic adenoid cystic carcinoma showing disease progression.
Not a fit: Patients with symptomatic central nervous system metastases or those who have received certain prior therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced adenoid cystic carcinoma.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies targeting adenoid cystic carcinoma have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.