Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma

Phase 2

Recruiting

• Conditions: Adenoid Cystic Carcinoma; Head and Neck Cancer
• Interventions: Drug: HG146

• Registration Number: NCT06781567
• Lead Sponsor: HitGen Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-13
• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Primary Completion: 2028-12-31
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical Trial of HG146 Administered to participants with Adenoid cystic carcinoma	HG146	Experimental: HG146 Monotherapy Arm Description: Participants will receive HG146 per os at every two days intervals (qod) for 14 consecutive days,7 days off, 21 days/ cycle.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Progression-Free Survival （PFS）	From enrollment to treatment at 12 months	PFS 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
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
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
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.

Trial Locations

Locations (1)

Shanghai Oriental Hospital; 🇨🇳 Shanghai, Shanghai, China