Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHitGen Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HG146
Treatment groups
140 Participants
are divided into 1 treatment groupLocations
1Shanghai Oriental Hospital200000, ShanghaiShanghai Municipality, China
Sponsors and collaborators
HitGen Inc.
Lead sponsor
Source ClinicalTrials.gov