Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma

NCT ID: NCT06781567

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-13
• Study Completion Date: 2029-06-30

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.

Conditions

Adenoid Cystic Carcinoma; Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinical Trial of HG146 Administered to participants with Adenoid cystic carcinoma

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.

Group Type: EXPERIMENTAL

HG146

Intervention Type: DRUG

HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.

Interventions

HG146

HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.

Intervention Type: DRUG

Other Intervention Names

HG146 Capsule

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HitGen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ye Guo

Role: PRINCIPAL_INVESTIGATOR

Shanghai Oriental Hospital

Locations

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie Shen

Role: CONTACT

jie.shen@hitgen.com

8268-85197385 ext. 8211

Facility Contacts

Ye Guo

Role: primary

pattrickguo@gmail.com

8268-85197385

Other Identifiers

HG146CN201

Identifier Type: -

Identifier Source: org_study_id