NCT06781567

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: HitGen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2024-12-13
• Primary completion: 2028-12-31
• Completion: 2029-06-30
• First posted: 2025-01-17
• Last updated: 2025-03-14

Locations

1 site across 1 country: China