Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma

Launched by HITGEN INC. · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HG146 for patients with adenoid cystic carcinoma, a type of cancer that can occur in the head and neck. The trial is divided into two stages, starting with 40 participants to gather information on how effective and safe the treatment is. If the results are promising, the study will continue with an additional 100 participants. This is a Phase II trial, which means they are looking closely at whether the drug works and how well it is tolerated by patients.

To be eligible for this trial, participants should be at least 18 years old and have recurrent or metastatic adenoid cystic carcinoma that has shown signs of worsening within the past year. They also need to have a good physical status and enough organ function to participate. Participants can expect regular check-ups and assessments throughout the trial to monitor their health and response to the treatment. It's important to note that certain health conditions and recent treatments may exclude someone from joining, so potential participants should discuss their individual situation with their doctor.

Gender

ALL

Eligibility 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.