Recruiting NCT06781567
Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HG146.
- Who it may be relevant to
- Registry conditions: Adenoid Cystic Carcinoma, Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase Il Clinical Study to Evaluate the Efficacy and Safety of HG146 Capsules in Participants with Recurrent or Metastatic Adenoid Cystic Carcinoma.
Overview
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
- Drug HG146
HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.
Primary outcome measures
- objective response rate (ORR) [Time frame: From enrollment to the end of treatment at 4 weeks]
- 6 Months Progression-Free Survival （PFS） [Time frame: From enrollment to treatment at 6 months.]
Secondary outcome measures (6)
- Progression-Free Survival （PFS） [Time frame: From enrollment to treatment at 12 months]
- Duration of response (DoR) [Time frame: From enrollment to the end of treatment at 4 weeks]
- Disease control rate (DCR) [Time frame: From enrollment to the end of treatment at 4 weeks]
- Overall survival (OS) [Time frame: From enrollment to the end of treatment at 4 weeks]
- Time-to-response (TTR) [Time frame: From enrollment to the end of treatment at 4 weeks]
- Population pharmacokinetics (PopPK) [Time frame: From Cycle1 Day7 to Day13, 21 days per cycle]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Oriental Hospital — Shanghai
Identifiers
NCT: NCT06781567 · HG146CN201