Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma

NCT06781567 | Recruiting Phase 2

• 1 other identifier: HG146CN201
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

HG146; HG146CN201

Outcome Measures

Primary Outcomes (2)

• objective response rate (ORR)

  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）

  PFS will be assessed by the investigators using RECIST v. 1.1

  From enrollment to treatment at 6 months.

Secondary Outcomes (6)

• Progression-Free Survival （PFS）

  From enrollment to treatment at 12 months

• Duration of response (DoR)

  From enrollment to the end of treatment at 4 weeks

• Disease control rate (DCR)

  From enrollment to the end of treatment at 4 weeks

• Overall survival (OS)

  From enrollment to the end of treatment at 4 weeks

• Time-to-response (TTR)

  From enrollment to the end of treatment at 4 weeks

Study Arms (1)

Clinical Trial of HG146 Administered to participants with Adenoid cystic carcinoma

EXPERIMENTAL

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

Interventions

HG146 DRUG

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

Also known as: HG146 Capsule

Clinical Trial of HG146 Administered to participants with Adenoid cystic carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HitGen Inc.: lead

Study Sites (1)

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Ye Guo

  Shanghai Oriental Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Shen

CONTACT

8268-85197385; jie.shen@hitgen.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 17, 2025
• Study Start: December 13, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)