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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
HG146
DrugHG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: Clinical Trial of HG146 Administered to participants with Adenoid cystic carcinomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
objective response rate (ORR)
ORR will be assessed by the investigators using RECIST v1.1
Time frame
From enrollment to the end of treatment at 4 weeks2
6 Months Progression-Free Survival （PFS）
PFS will be assessed by the investigators using RECIST v. 1.1
Time frame
From enrollment to treatment at 6 months.Secondary outcomes
1
Progression-Free Survival （PFS）
PFS will be assessed by the investigators using RECIST v1.1
Time frame
From enrollment to treatment at 12 months2
Duration of response (DoR)
DOR will be assessed by the investigators using RECIST v1.1
Time frame
From enrollment to the end of treatment at 4 weeks3
Disease control rate (DCR)
DCR will be assessed by the investigators using RECIST v1.1
Time frame
From enrollment to the end of treatment at 4 weeks4
Overall survival (OS)
OS will be assessed by the investigators
Time frame
From enrollment to the end of treatment at 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov