RecruitingPhase 2NCT06781567

Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma

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


Sponsor

HitGen Inc.

Enrollment

140 participants

Start Date

Dec 13, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HG146 (an HDAC inhibitor) in people with adenoid cystic carcinoma — a rare type of cancer that most often appears in salivary glands, but can also occur in other parts of the head, neck, breast, or trachea. The drug aims to slow or stop cancer growth by blocking proteins that help cancer cells survive. **You may be eligible if...** - You are 18 or older - You have recurrent or metastatic adenoid cystic carcinoma that has progressed within the past year - You have at least one measurable tumor - You are in good general health (ECOG 0–1) - Your organs (heart, liver, kidneys) are functioning adequately **You may NOT be eligible if...** - You have brain metastases requiring steroids - You have previously been treated with an HDAC-targeting drug - You received chemotherapy or other anti-cancer therapy within 3–4 weeks before starting this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHG146

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


Locations(1)

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, China

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NCT06781567


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