Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma (HG146)

March 11, 2025 updated by: HitGen Inc.

A Phase Il Clinical Study to Evaluate the Efficacy and Safety of HG146 Capsules in Participants with Recurrent or Metastatic Adenoid Cystic Carcinoma.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai Oriental Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: HG146
HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.
Other Names:
  • HG146 Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate (ORR)
Time Frame: From enrollment to the end of treatment at 4 weeks
ORR will be assessed by the investigators using RECIST v1.1
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.
PFS will be assessed by the investigators using RECIST v. 1.1
From enrollment to treatment at 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival （PFS）
Time Frame: From enrollment to treatment at 12 months
PFS will be assessed by the investigators using RECIST v1.1
From enrollment to treatment at 12 months
Duration of response (DoR)
Time Frame: From enrollment to the end of treatment at 4 weeks
DOR will be assessed by the investigators using RECIST v1.1
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
DCR will be assessed by the investigators using RECIST v1.1
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
OS will be assessed by the investigators
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
TTR will be assessed by the investigators using RECIST v1.1
From enrollment to the end of treatment at 4 weeks
Population pharmacokinetics (PopPK)
Time Frame: From Cycle1 Day7 to Day13, 21 days per cycle
PopPK will be detected to predict exposure level of HG146 in human body.
From Cycle1 Day7 to Day13, 21 days per cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HitGen Inc.

Investigators

  • Principal Investigator: Ye Guo, Shanghai Oriental Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HG146CN201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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