Actively Recruiting
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HG146 Capsules in Participants with Recurrent or Metastatic Adenoid Cystic Carcinoma
Led by HitGen Inc. · Updated on 2025-03-14
140
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical efficacy and safety of HG146 in adults with recurrent or metastatic adenoid cystic carcinoma, a type of head and neck cancer. This Phase II, open-label, non-randomized, multicenter trial aims to assess how well HG146 works and how safe it is for this patient group. The study will enroll 40 participants in the first stage to gather initial data before deciding whether to continue to a second stage with an additional 100 participants. Participants receive HG146 capsules taken orally every two days for 14 days, followed by a 7-day break, completing a 21-day treatment cycle. This treatment schedule continues throughout the study. The investigational drug is provided as 5 mg or 10 mg capsules. The trial does not use a placebo or blinding, and all participants receive the study drug. During the study, participants will be monitored regularly to assess tumor response and disease progression using imaging and clinical evaluations. Key outcomes include objective response rate and progression-free survival at 4 weeks and 6 months post-enrollment. Additional measures assess overall survival, duration of response, disease control rate, time to response, and drug pharmacokinetics. Participants' health status and organ function will be evaluated to ensure safety throughout the trial, which lasts until the study end in June 2029.
CONDITIONS
Brief Title
Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form (ICF) and able to comply with study requirements
- Age 18 years or older, any gender
- Recurrent or metastatic adenoid cystic carcinoma with disease progression within one year after diagnosis
- Estimated survival longer than 12 weeks as determined by the investigator
- Eastern Cancer Consortium (ECOG) physical status score of 0 or 1
- Adequate organ function
- At least one measurable tumor lesion according to RECISTv1.1 criteria
You will not qualify if you...
- Symptomatic central nervous system (CNS) metastases requiring steroids within 4 weeks prior to starting study treatment
- Prior therapies targeting HDAC
- Chemotherapy within 21 days before first study treatment dose
- Other anti-tumor therapies within 28 days before first study treatment dose
- Use of strong CYP3A4 inhibitors or inducers within 7 days before starting treatment
- Major surgery or major injury within 28 days before first dose or planned major surgery during study
- Prior allogeneic bone marrow or other solid organ transplantation
- Active infections requiring systemic treatment
- Other malignancies within the last 5 years except certain treated skin and cervical cancers
- Known allergy to study drug or its ingredients
- Pregnant or breastfeeding women
- History of drug or chronic alcohol abuse affecting study evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles
Participants receive HG146 capsules orally every two days for 14 consecutive days followed by 7 days off in 21-day cycles.
Visits every 21 days per cycle
Trial Site Locations
Total: 1 location
1
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
J
Jie Shen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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