Adenoid Cystic Carcinoma, Head and Neck Cancer
Conditions
Keywords
HG146, HG146CN201
Brief summary
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.
Interventions
DRUGHG146
HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.
Sponsors
HitGen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | From enrollment to the end of treatment at 4 weeks | ORR will be assessed by the investigators using RECIST v1.1 |
| 6 Months Progression-Free Survival （PFS） | From enrollment to treatment at 6 months. | PFS will be assessed by the investigators using RECIST v. 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | From enrollment to the end of treatment at 4 weeks | DCR will be assessed by the investigators using RECIST v1.1 |
| Overall survival (OS) | From enrollment to the end of treatment at 4 weeks | OS will be assessed by the investigators |
| Progression-Free Survival （PFS） | From enrollment to treatment at 12 months | PFS will be assessed by the investigators using RECIST v1.1 |
| Population pharmacokinetics (PopPK) | From Cycle1 Day7 to Day13, 21 days per cycle | PopPK will be detected to predict exposure level of HG146 in human body. |
| Time-to-response (TTR) | From enrollment to the end of treatment at 4 weeks | TTR will be assessed by the investigators using RECIST v1.1 |
| Duration of response (DoR) | From enrollment to the end of treatment at 4 weeks | DOR will be assessed by the investigators using RECIST v1.1 |
Countries
China
Contacts
Primary ContactJie Shen
Outcome results
None listed