Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma

Sponsor
HitGen Inc.
Study ID
NCT06781567
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 13, 2024
Status verified
Jan 2025
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

objective response rate (ORR) [ Time Frame: From enrollment to the end of treatment at 4 weeks ]

Central Contacts

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