A Phase Il Clinical Study to Evaluate the Efficacy and Safety of HG146 Capsules in Participants with Recurrent or Metastatic Adenoid Cystic Carcinoma.
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.
• 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.