Actively Recruiting
Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma
Led by HitGen Inc. · Updated on 2025-03-14
140
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 and able to comply with study requirements
- Age 18 years or older, any gender
- Recurrent or metastatic adenoid cystic carcinoma with progression within one year of diagnosis
- Estimated survival greater than 12 weeks as determined by investigator
- Eastern Cancer Consortium (ECOG) physical status score of 0 or 1
- Adequate organ function
- At least one measurable tumor lesion per RECIST v1.1 criteria
You will not qualify if you...
- Symptomatic central nervous system metastases requiring steroids within 4 weeks prior to first dose
- Prior therapies targeting HDAC
- Chemotherapy within 21 days or other anti-tumor therapies within 28 days before first dose
- Use of strong CYP3A4 inhibitors or inducers within 7 days before first dose
- Major surgery or major injury within 28 days before first dose or planned major surgery during study
- Prior allogeneic bone marrow or solid organ transplantation
- Active infection requiring systemic treatment
- Current or past other malignancies unless treated with no recurrence in last 5 years
- Known allergy to investigational drug components
- Pregnant or lactating women
- History of drug abuse or chronic alcohol abuse affecting study evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
J
Jie Shen
CONTACT
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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